September 30, 2021

Siemens Medical Solutions USA, Inc.

℅ Tabitha Estes
Regulatory Affairs Specialist
810 Innovation Drive
KNOXVILLE TN 37932

Re: K211591
Trade/Device Name: NAEOTOM Alpha, Scan&GO
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed tomography x-ray system
Regulatory Class: Class II
Product Code: JAK
Dated: August 19, 2021
Received: August 20, 2021

Dear Tabitha Estes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.28
Silver Spring, MD 20993
www.fda.gov
K211591 - Tabitha Estes Page 2

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,
Laurel M. Digitally signed by
Laurel M. Burk -S

Burk -S Date: 2021.09.30

10:22:31 -04'00' , for
Thalia T. Mills, Ph.D.
Director
Division of Radiological Health
OHT7: Office of In Vitro Diagnostics
and Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: 0MB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.

51 0(k) Number (if known)

K211591
Device Name
NAEOTOM Alpha
Scan&GO

Indications for Use (Describe)

NAEOTOM Alpha
This computed tomography system is intended to generate and process cross-sectional images of patients by computer
reconstruction ofx-ray transmission data.

The images delivered by the system can be used by a trained physician as an aid in diagnosis.
The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation
therapy planning.

This CT system can be used for low dose lung cancer screening in high risk populations.*

*As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung
Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Scan&GO
This in-room scan application is a planning and information system designed to perform the necessary functions required
for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the
scanner.

The in-room scan application runs on standard information technology hardware and software, utilizing the standard
information technology operating systems and user interface. Communication and data exchange are done using special
protocols.

Type of Use (Select one or both, as applicable)

IZI Prescription Use (Part 21 CFR 801 Subpart D) D Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid 0MB number."

FORM FDA 3881 (6120) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 37 of 165
 K211591

510(K) SUMMARY
FOR
NAEOTOM ALPHA CT SCANNER AND SCAN&GO
Submitted by:
Siemens Medical Solutions USA, Inc.
810 Innovation Drive
Knoxville, TN 37932
Date Prepared: February 21, 2021

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the
requirements of SMDA 1990 and 21 CFR §807.92.

I. Submitter
Siemens Medical Solutions USA, Inc.
810 Innovation Drive
Knoxville, TN 37932
Establishment Registration Number
1034973

Importer/Distributor
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355
Establishment Registration Number
2240869

Location of Manufacturing Site (1)

Siemens Healthcare GmbH
Siemensstr. 1
D-91301 Forchheim, Germany
Establishment Registration Number
3004977335

Location of Manufacturing Site (2)

SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD
278 Zhou Zhu Rd
Shanghai, CHINA, 201318
Establishment Registration Number:
3003202425

Note: Description in this submission use the short company name Siemens. It covers both
manufacturing locations and names as listed above. Brand name on all products is Siemens
Healthineers.

Contact Person:
Tabitha Estes
Regulatory Affairs
Siemens Medical Solutions USA, Inc.
(865) 804-4553 (work cell)
(865) 218-3019 FAX
II. Device Name and Classification
Product Name: NAEOTOM Alpha
Trade Name: NAEOTOM Alpha
Classification Name: Computed Tomography X-ray System
Classification Panel: Radiology
Regulation Number: 21 CFR §892.1750
Device Class: Class II
Product Code: JAK

Product Name: Scan&GO

Propriety Trade Name: Scan&GO
Classification Name: Computed Tomography X-ray System
Secondary Classification Name: Picture Archiving and Communications System
Classification Panel: Radiology
CFR Section: 21 CFR §892.1750
Secondary CFR Section: 21 CFR §892.2050
Device Class: Class II
Product Code: JAK
Secondary Product Code: LLZ

III. Predicate Device

Primary Predicate Device:
Trade Name: SOMATOM Force

510(k) Number: K190578

Clearance Date: June 27, 2019
Classification Name: Computed Tomography X-ray System
Classification Panel: Radiology
Regulation Number: 21 CFR §892.1750
Device Class: Class II
Product Code: JAK
Recall Information: All predicate device recalls have been considered in the subject device
design.

Secondary Predicate Device:

Trade Name: SOMATOM X.cite, Scan&GO

510(k) Number: K200524

Clearance Date: April 01, 2020
Classification Name: Computed Tomography X-ray System
Classification Panel: Radiology
Regulation Number: 21 CFR §892.1750
Device Class: Class II
Product Code: JAK
Recall Information: All predicate device recalls have been considered in the subject device
design.

Note: K200524 was a bundle submission with various Siemens CT Scanner Systems, including
SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim,
SOMATOM go.Open Pro, SOMATOM X.cite and Scan&GO software.

In this submission, the primary predicate device SOMATOM Force and the secondary predicate
device SOMATOM X.cite including Scan&GO are being used, to demonstrate substantial equivalence
of technological characteristics.
IV. Device Description
Siemens intends to market a new CT scanner system NAEOTOM Alpha supporting
software version, SOMARIS/10 syngo CT VA40 with mobile workflow options.

Dual Source CT Scanner System:

• NAEOTOM Alpha
• Scan&GO Mobile Medical Application (optional mobile workflow component)

The subject device NAEOTOM Alpha with SOMARIS/10 syngo CT VA40 is a dual-source Computed
Tomography (CT) x-ray system featuring two detectors based on new photon counting technology.
The CT scanner system algorithm is designed to allow image reconstruction by using photon counting
data generated by the subject device. The reconstruction results are comparable with the predicate
devices, but support with improved technological characteristics.

The NAEOTOM Alpha with Software SOMARIS/10 syngo CT VA40 produces CT images in DICOM
format, which can be used by trained staff for post-processing applications commercially distributed by
Siemens and other vendors as an aid in diagnosis, treatment preparation and therapy planning support
(including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam
Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional
post processing applications.

The Scan&GO mobile workflow is an optional planning and information software designed to perform
the necessary functions required for planning and controlling of the workflow of the NAEOTOM Alpha.
Scan&GO can be operated on a Siemens provided various tablet hardware that meets certain minimum
technical requirements.
NOTE: Scan&GO does not support storage of images. Additionally, Scan&GO cannot trigger a scan
or radiation release.

The software version for the NAEOTOM Alpha, syngo CT VA40 (SOMARIS/10 syngo CT VA40), is a
command-based program used for patient management, data management, X-ray scan control,
image reconstruction, and image archive/evaluation.
The software platform provides a software plugin interface that allows for the use of specific
commercially available post processing software algorithms in an unmodified form from the cleared
stand-alone post processing version.
New software version syngo CT VA40 (SOMARIS/10 syngo CT VA40) is a modified software version
based on syngo CT VA30A (SOMARIS/10 syngo CT VA30) which was cleared for the secondary
predicate device and supports the same plugin interfaces for the subject device Scan&GO mobile
workflow and integration of post-processing tasks as the secondary predicate device Scan&GO cleared
in (K200524).

V. Indications for Use

NAEOTOM Alpha:
This computed tomography system is intended to generate and process cross-sectional images of
patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained physician as an aid in diagnosis.
The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment
preparation and radiation therapy planning.

This CT system can be used for low dose lung cancer screening in high risk populations.*

*As defined by professional medical societies. Please refer to clinical literature, including the results of
the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for
further information.
Scan&GO:
This in-room scan application is a planning and information system designed to perform the
necessary functions required for planning and controlling scans of supported SIEMENS CT scanners.
It allows users to work in close proximity to the scanner.

The in-room scan application runs on standard information technology hardware and software,
utilizing the standard information technology operating systems and user interface. Communication
and data exchange are done using special protocols.

VI. Comparison of Technological Characteristics with the Predicate Device

The NAEOTOM Alpha scanner provides comparable technological characteristics in terms of materials,
energy source, and control mechanisms when compared to the primary predicate device SOMATOM
Force. The software and hardware components of this scanner have been modified or improved in
comparison to the predicate devices to support enhanced device functionality and a to introduce a new
detector technology.

The subject device NAEOTOM Alpha is building on the dual-source CT system configuration of the
primary predicate device SOMATOM Force.
NAEOTOM Alpha features comparable technological characteristics of a Siemens dual-source CT
system, such as fast scan speed and temporal resolution down to 66ms. It uses the same general
geometric dimensions of the measurement field (such as detector z coverage and scan-field-of-view)
in comparison to the primary predicate device SOMATOM Force CT scanner system.
As a dual source CT scanner system, the primary predicate device SOMATOM Force features two
conventional energy-integrating detectors made of scintillator ceramic (product marketing name “Ultra
Fast Ceramic”, abbreviated UFC, based on scintillator ceramic). The subject device NAEOTOM Alpha
features two photon counting detectors built from Cadmium-Telluride (CdTe).

Supported by the subject device, SOMARIS/10 syngo CT VA40 software version is a further
development of the SOMARIS/10 syngo CT VA30 software version which is cleared in K200524.
It reuses all unmodified software features of the legacy software syngo CT VA30 as described below
in the section “Unmodified Features used in the Subject Devices”.

As with the secondary predicate device SOMATOM X.cite, the subject device NAEOTOM Alpha is
supported by an optional mobile workflow, Scan&GO. Scan&GO has been modified to add new iPad
hardware and operating software that supports the application software installation.

Software version SOMARIS/10 syngo CT VA40 is designed to reuse hardware independent extended
functionalities and GO technologies provided by Siemens cleared software applications. The intended
use and fundamental scientific technology for the NAEOTOM Alpha remains unchanged from the
cleared predicate devices.

At a high level, the subject device NAEOTOM Alpha and the primary predicate device SOMATOM
Force or the secondary predicate device SOMATOM X.cite are based on the same subset of
technological elements:
• Scanner Principle- Whole body X-Ray Computed Tomography Scanner
• System Acquisition – Continuously rotating tube detector system
• Iterative Reconstruction – Support of various iterative reconstruction principles
• Workplaces – Support of workplaces that include reconstruction and image evaluation software
• Patient table
• Patient table foot switch for movement
• Tin filtration technology
• Vectron X-ray Tube
• Power Generator
• Mobile Medical application Software functionality (Scan&GO)
• Mobile workflow (Tablet)
• Support 3D Camera operation for fast patient positioning workflow
 • Scanner display and control functionality
• Remote Scan Control
• Long scan range

The following technological differences exist between the subject device NAEOTOM Alpha and
the primary predicate device SOMATOM Force or the secondary predicate device SOMATOM
X.cite:
• Software version SOMARIS/10 syngo CT VA40
• Support updated cybersecurity features
• Additional options for Inline and GO technologies
• Iterative Reconstruction Methods
• QuantaMax Detector based on Quantum Technology

The following technological differences exist between the subject device Scan&GO mobile
application software and the secondary predicate device Scan&GO mobile application software
cleared in K200524:
• Software version SOMARIS/10 syngo CT VA40
• iPad hardware to support mobile workflow options

The NAEOTOM Alpha will support the following modifications/further developments in comparison to
the predicate devices as listed in the tables below.

The configuration table and comparison table use the following terms to describe various technological
characteristics in comparison to the predicate device information:
Table 01: Overview term definition
Term Definition
N/A The feature is not supported for the subject device
New The feature is newly supported for Siemens CT Scanners and the subject device
Modified This feature is modified from the predicate devices
Unmodified This feature remains unchanged from the predicate device
This feature is currently supported by other cleared Siemens CT systems or cleared
Siemens stand-alone software applications. This feature will be supported for the subject
enabled
device with software version SOMARIS/10 syngo CT VA40 and is substantially equivalent
compared to the cleared version.

New/modified hardware features:

Table 02: Overview of hardware modifications of NAEOTOM Alpha

Subject Device
Hardware properties supported by SOMARIS/10 syngo CT VA40 NAEOTOM Alpha
01 Detector - QuantaMax new
02 Tablet hardware for Scan&GO - iPad modified
03 Patient Table Configuration modified

New software version SOMARIS/10 syngo CT VA40 with enabled, modified and new software
features:
Table 03: Overview of software modifications of NAEOTOM Alpha
Subject Device
Software properties supported by SOMARIS/10 syngo CT VA40 NAEOTOM Alpha
01 Precision Matrix (1024²) (large image matrices) enabled
02 Quantum Iterative Reconstruction new
03 Always Dual Energy new
04 Calcium scoring with keV images modified
05 Imaging – Cardio BestPhase enabled
06 CARE keV new
07 Quantum Pure Lumen new
08 Cardiac CT imaging - Motion artifact reduced ECG-gated imaging modified
09 Motion artifact reduced non-gated imaging modified
 Subject Device
Software properties supported by SOMARIS/10 syngo CT VA40 NAEOTOM Alpha
10 myExam Console and myExam Satellite modified
11 Recon&GO Inline Results - DE SPP modified
12 Recon&GO Spectral Recon modified

A tabular summary of the comparable hardware and software properties between the subject device
NAEOTOM Alpha with software version syngo CT VA40 and predicate devices are listed in Table 04
and Table 05 below (only the changes from the predicate devices are highlighted in gray in the
sections below sections).

Table 04: NAEOTOM Alpha comparable hardware properties (modified)

subject device primary predicate device secondary predicate device
Hardware
NAEOTOM Alpha SOMATOM Force SOMATOM X.cite
properties
Dual Source Dual Source Single Source
whole body X-ray computed whole body X-ray computed whole body X-ray computed
Scanner
tomography scanner tomography scanner tomography scanner
Generator
2x 120 kW 2x 120 kW 105 kW
max. power
Detector Direct Conversion with Energy-integrating Energy-integrating
technology “Quantum Technology”
Detector
2 x 57.6 mm 2 x 57.6 mm 38.4 mm
volume coverage
Detector
2 x 288 2 x 96 64
physical rows
Detector
0.2 mm 0.6 mm 0.6 mm
slice width
Detector 2752 (A system) 920 (A system)
840
channel No. 1984 (B system) 640 (B system)
X-ray Tube Vectron Vectron Vectron
Tube 90 kV, 100 kV, (in 10kV steps) (in 10kV steps)
kV steps 120 kV, 140 kV 70 kV to 150kV 70 kV to 150kV
Tube
2 x 1300 mA 2 x 1300 mA 1200 mA
max. current
0.4×0.5 mm / 0.6x0.7 mm / 0.4×0.5 mm / 0.6×0.7 mm /
Tube
0.8x1.1 mm 0.8x1.1 mm 0.6x0.7 mm / 0.8x1.1 mm
tube focus
(for both tubes) (for both tubes)
Tube
higher than 30 MHU higher than 30 MHU higher than 30 MHU
heat capacity
Tube adaptive dose shied adaptive dose shied adaptive dose shied
Collimator supported supported supported

Gantry 82 cm 78 cm 82 cm
bore size
Gantry
50 cm 50 cm 50 cm
Scan FoV
Gantry 0.25s, 0.285s, 0.33s, 0.5s,
0.25s; 0.5s; 1.0s; 0.3s, 0.5s, 1.0s
rotation time (sec) 1.0s
Gantry
N/A N/A +/- 25
Tilt (degree)
Patient Table Vario 2.D: 2000 mm, PHS5, MPT4: Vario RT: 1600 mm,
type Vitus: 2000 mm 1600 mm or 2000 mm Vario 2: 2000 mm
Max. Scan length Vario 2.D: 2080 mm,
1600 mm, 2000 mm 1680 mm, 2080 mm
Topogram Vitus: 2080 mm
Max. Scan length Vario 2.D: 2000 mm,
1600 mm, 2000 mm 1600 mm, 2000 mm
Image acquisition Vitus: 2000 mm
Combined Split Filter / Tin
Spectral filtration Tin Filter for both tubes Tin Filter for both tubes Filter supported, plus extra
Option* Tin Filter

3D Camera option for patient positioning option for patient positioning option for patient positioning
for patient positioning with 3D Camera with 3D Camera with 3D Camera
Table 05: NAEOTOM Alpha comparable software properties
subject device primary predicate device secondary predicate device
Properties NAEOTOM Alpha SOMATOM Force SOMATOM X.cite
software
(syngo CT VA40 ) (K190578) (syngo CT VB20) (K200524)
Windows based Windows based Windows based
Operating
SOMARIS/10 SOMARIS/7 SOMARIS/10
System
syngo CT VA40 syngo CT VB20 syngo CT VA30 A
syngo Acquisition Workplace syngo Acquisition Workplace syngo Acquisition Workplace
(AWP) (AWP) (AWP)
syngo Viewing, syngo Filming syngo Viewing, syngo Filming syngo Viewing, syngo Filming
Acquisition and syngo Archiving & and syngo Archiving & and syngo Archiving &
Workplace Networking Networking Networking
2nd Acquisition Workplace 2nd Acquisition Workplace: No 2nd Acquisition Workplace
supported with myExam RRWP supported
Satellite
Image Reconstruction from Image Reconstruction from Image Reconstruction from
IRS photon counting data classic Siemens dual source classic Siemens single source
CT scanner CT scanner
QuantaMax detector firmware Stellar detector firmware Stellar detector firmware
Detector
supported supported supported
Teamplay Support teamplay Protocols Support teamplay Protocols Support teamplay Protocols
Support of: Support of: Support of:
• Protocols for Radiation • Protocols for Radiation
Therapy Planning Therapy Planning support
• Protocol supporting • Protocol supporting patient marking
contrast bolus-triggered contrast bolus-triggered • Protocol supporting
data acquisition data acquisition contrast bolus-triggered
• Contrast media protocols • Contrast protocols – CARE data acquisition
• Pediatric Protocols Contrast III • Contrast media protocols
• Flex Dose Profile • Pediatric Protocols • Pediatric Protocols
Protocols • Turbo Flash Spiral • Flex Dose Profile • Flex Dose Profile
• Dual Energy acquisition • Turbo Flash Spiral • TwinBeam DE
• Dual Energy acquisition • TwinSpiral DE
• Adaptive 4D Spiral • Flex 4D Spiral
• Protocols that allow • Protocols that allow
scanning with support of scanning with support of
an 3rd party respiratory an 3rd party respiratory
gating system (ANZAI, gating system (ANZAI,
Varian RGSC) Varian RGSC)

Recon&GO – Advanced reconstruction tools Advanced reconstruction tools

- Spectral Recon (Dual Energy supported: supported via Recon&GO_
Reconstruction from photon The syngo acquisition - Spectral Recon (Dual Energy
counting data) / including workplace provides, image Reconstruction)
Virtual Unenhanced, reconstruction, and routine - Inline Results DE SPP
Monoenergetic plus postprocessing. Various (Spectral Post-Processing) /
Advanced
- Inline Results DE SPP advanced reconstruction including
Reconstruction
(Spectral Post-Processing with features supported by the CT Virtual Unenhanced,
photon counting image data) Scanner, e.g., FAST and CARE Monoenergetic plus
applications. - Inline Results DE Ranges
(Parallel/Radial) / Inline DE

Software Plugin functions syngo.via - Wide Range of Software Plugin functions

enabled via software interface individual applications, enabled via software interface
Post-
Recon&GO - Inline Results syngo.via is a software solution Recon&GO - Inline Results
Processing
various methods of cleared intended to be used for various methods of cleared
software applications viewing, manipulation, software applications
communication, and storage of
medical images. It can be used
as a standalone device or
together with a variety of
 subject device primary predicate device secondary predicate device
Properties NAEOTOM Alpha SOMATOM Force SOMATOM X.cite
software
(syngo CT VA40 ) (K190578) (syngo CT VB20) (K200524)
cleared and unmodified syngo
based software options.
Cybersecurity IT Hardening IT Hardening IT Hardening
• FAST Features • FAST Features • FAST Features
Standard • CARE Features • CARE Features • CARE Features
Technologies • GO technology • GO technology
• CARE keV • CARE kV • CARE kV
Iterative Quantum Iterative iMAR, SAFIRE, ADMIRE iMAR, ADMIRE
Reconstruction Reconstruction
Methods
Precision Matrix resolution Precision Matrix resolution Matrix resolution 512x512
support image matrix sizes of support image matrix sizes of (auto mode not supported)
Precision
512x512, 768x768 pixels and 512x512, 768x768 pixels and
Matrix
1024x1024 pixel (auto mode 1024x1024 pixel (auto mode
supported) supported)
Photon counting technology Classic SOMATOM Force Classic SOMATOM X.cite
offers monoenergetic images technology offers images technology offers images
which can be used as a base which can be used for calcium which can be used for calcium
for calcium scoring scoring, independent from scoring, independent from
Ca Scoring
independent from tube voltage tube voltage kV and beam tube voltage kV and beam
kV and beam filtration settings. filtration settings based on a filtration settings based on a
dedicated single energy image dedicated single energy image
reconstruction method. reconstruction method.

Any differences in technological characteristics do not raise different questions of safety and
effectiveness. Siemens believes that the subject device is substantially equivalent to the predicate
devices. Testing and validation are completed. Test results show that the subject device, the
NAEOTOM Alpha, is comparable to the predicate devices in terms of technological characteristics
and safety and effectiveness and therefore is substantially equivalent to the primary predicate
SOMATOM Force and secondary predicate device SOMATOM X.cite.

VII. Performance Data

Non Clinical Testing

Non-clinical testing, (integration and functional) including phantom tests were conducted for the
NAEOTOM Alpha during product development. The modifications described in this Premarket
Notification were supported with verification and validation testing.

The general purpose of each tests is to verify and validate the functionality of the subject device
modifications.

Testing will cover all related subsystems that contribute to the device modifications. Test levels are
defined. For each test level several test activities are performed. The test specification and
acceptance criteria are related to the corresponding requirements. Various test activities are
performed to specific modifications on different test levels to ensure safe and effective integration in
the system. Three test levels are defined:

System Validation test:

• Acceptance test (workflow and user manual test)
• Legal and Regulatory test

System Verification test:

• System Integration Test (functional)
• Functionality verification
• Image Quality (IQ) Evaluation
Tests are conducted for all software components developed in product development and for the
complete product itself. Several activities are considered for this process, including creation of test
specifications that relate to software/hardware requirements including tests to address risk mitigations
that are identified, documented and traced by hazard keys.

Additional evaluation tests are performed as bench tests to support the new device or device
modification on Non-Clinical Performance Testing as listed in table 07 below.

Table 06: Non-Clinical Performance Testing

# Feature Non-Clinical Performance Testing
01 Quantum Iterative Reconstruction Quantum Iterative Reconstruction - QIR is routinely used in all
reconstructions on the subject device NAEOTOM Alpha.
As with the primary predicate device SOMATOM Force supporting
ADMIRE, the subject device supports iterative reconstruction principle.
NAEOTOM Alpha supports Quantum Iterative Reconstruction with
image data generated with Quantum Technology (QuantaMax
Detector) and optimized for photon counting data.
Iterative Beam Hardening Correction - IBHC is an iterative Beam
Hardening Correction algorithm optimized for the subject device
NAEOTOM Alpha.
Performance testing was done to support all technological
characteristics, that are associated with this new technology.
02 Detector – QuantaMax The subject device NAEOTOM Alpha supports two “QuantaMax”
detectors for CT data acquisition. The QuantaMax detectors are built
on the new “Quantum Technology” which is Siemens Healthineers’
implementation of photon counting technology for CT detectors.
The performed tests include the measurement and analysis of raw
data for single photon counting, the nonexistence of classical noise
and the ability to measure multiple energies simultaneously.
Furthermore, the performance evaluation provides an in-depth
evaluation of NAETOM Alpha Image Quality for general CT imaging,
based on phantom evaluation of Typical Modes, compared to the
predicate device SOMATOM Force. It also includes parameters for
supporting the suitability of the subject device for low dose lung cancer
screening.
05 Cardiac CT imaging - Motion As with the primary predicate device the subject device supports ECG-
artifact reduced ECG-gated gated imaging based on ECG-controlled dose modulation and
imaging triggering derived from continuous monitoring of the ECG. With same
technological principle as cleared with the primary predicate device,
the subject device supports with an unmodified algorithm, the desired
prediction of the target start- and stop phase in retrospective spiral
and in sequence mode. The prediction of the start phase in ECG
triggered high pitch scanning is modified to improve the prediction
over a wider range of heart rates.
The associated test evidence contains a basic test scenario and the
results of measurements based on an andromorphic motion heart
phantom to support the clinical approach based on technical phantom
measurements, which are to some extend clinically realistic.
06 CARE keV CARE kV is supported by the primary predicate device SOMATOM
Force. The subject device NAEOTOM Alpha based on Quantum
Technology supports CARE keV. CARE keV takes the dose efficiency
of Monoenergetic reconstructions into account, by automatically
adjusting the appropriate kV and effective mAs settings to optimize the
applied dose while the image quality is maintained. The test procedure
includes phantom measurements with clinically relevant phantom
diameters and contrast materials to support the contrast, noise, and
radiation dose related CARE keV information.
07 Quantum Pure Lumen The subject device NAEOTOM Alpha supports with its new feature
“VCR – Pure Lumen” a modified algorithm, which allows to reconstruct
with a virtual removal of calcium in spectral generated images with a
possible application in heavily calcified vessels.
Algorithm, clinical references and example images derived from
phantom based measurements. Performance testing was done to
support all technological characteristics, that are associated with this
new technology.
 # Feature Non-Clinical Performance Testing
08 Always Dual Energy The subject device NAEOTOM Alpha supports virtual monochromatic
images, virtual non-contrast images and iodine images for all
QuantumPlus scans, i.e., all scans with 120kV or 140kV without tin
filtration and not in UHR mode.
Performance testing was done to assess the accuracy of these three
image types on phantoms with iodine inserts.
09 Motion artifact reduced non- As with the primary predicate device SOMATOM Force the subject
gated imaging device supports spiral scanning at different pitch value of up to 3.2 in a
dual source acquisition and up to 1.5 in a single source acquisition.
These acquisitions at high pitch values and therefore table speeds
have the potential to minimize motion artifacts. This feature name and
detector hardware is modified. In comparison to the primary predicate
device SOMATOM Force, other technological characteristics to
support the feature remains unmodified.
Performance testing was done to confirm the characteristics to allow
improvement of motion artifacts. It also contains a basic test scenario
and the results of measurements based on an andromorphic motion
heart and respiratory phantom to support the clinical approach based
on technical phantom measurements, which are clinically realistic.
10 Calcium Scoring with keV Images As with the primary predicate device SOMATOM Force, the subject
device support CaScoring. With its photon counting detector
technology, the subject device software is modified to use its
generated monoenergetic images as a base for calcium scoring.
The performance evaluation used monoenergetic images
reconstructed at 70 keV with different QIR strength settings derived
from a counting detector technology acquisition of the subject device
NAEOTOM Alpha, which are suitable in the application of Agatston
Score base Coronary Calcium scoring.

Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the subject
device NAEOTOM Alpha in accordance with the following standards: 60601-2-44, and 60601-1-2. A
list of recognized and general consensus standards considered for the subject devices is provided as
Table 07 and Table 08 below.

Table 07: Recognized Consensus Standards

Standard Standard
Date of Recognition
Developing Designation Title of Standard
Recognition Number
Organization Number and Date
Digital Imaging and Communications
06/27/2016 12-300 NEMA PS 3.1 - 3.20 (2016)
in Medicine (DICOM) Set
07/06/2020 12-325 NEMA XR 25-2019 Computed Tomography Dose Check
Supplemental Requirements for User
01/27/2015 12-287 NEMA XR 28-2013 Information and System Function
Related to Dose in CT
14971:2007/(R)2010 Medical Devices - Applications Of
ANSI AAMI
(Corrected 4 Risk Management To Medical
ISO
October 2007) Devices
06/27/2016 5-40
Medical Devices - Applications Of
14971 Second
ISO Risk Management To Medical
edition 2007-03-01
Devices
62304 Edition 1.1
2015-06 Medical Device Software - Software
01/14/2019 13-79 IEC
CONSOLIDATED Life Cycle Processes
VERSION
C1:2009/(R)2012 and
A2:2010/(R)2012 (Consolidated
ES60601- Text) Medical electrical equipment -
07/09/2014 19-4 ANSI AAMI 1:2005/(R)2012 And Part 1: General requirements for
A1:2012, basic safety and essential
performance (IEC 60601-1:2005,
MOD)
ANSI AAMI Medical electrical equipment - Part 1-
09/17/2018 19-8 60601-1-2:2014
IEC 2: General requirements for basic
 Standard Standard
Date of Recognition
Developing Designation Title of Standard
Recognition Number
Organization Number and Date
safety and essential performance -
Collateral Standard: Electromagnetic
disturbances - Requirements and
tests
Medical devices - Part 1: Application
ANSI AAMI
12/23/2016 5-114 62366-1:2015 of usability engineering to medical
IEC
devices
Safety Of Laser Products - Part 1:
Equipment Classification, And
Requirements [Including: Technical
Corrigendum 1 (2008), Interpretation
60825-1 Edition 2.0
07/09/2014 12-273 IEC Sheet 1 (2007), Interpretation Sheet
2007-03
2 (2007)]
Note: Requirements according to
IEC 60825-1:2014 (Ed.3.0) are
implemented.
Medical electrical equipment - Part 2-
44: Particular requirements for the
60601-2-44 Edition
06/27/2016 12-302 IEC basic safety and essential
3.2: 2016
performance of x-ray equipment for
computed tomography
Medical electrical equipment - Part 1-
3: General requirements for basic
60601-1-3 Edition safety and essential performance -
01/14/2014 12-269 IEC
2.1 2013-04 Collateral Standard: Radiation
protection in diagnostic X-ray
equipment
Medical Electrical Equipment - Part
1-6: General Requirements For
60601-1-6 Edition
06/27/2016 5-89 IEC Basic Safety And Essential
3.1 2013-10
Performance - Collateral Standard:
Usability
Evaluation and routine testing in
medical imaging departments - Part
61223-2-6 Second
03/14/2011 12-226 IEC 2-6: Constancy tests - Imaging
Edition 2006-11
performance of computed
tomography X-ray equipment
Evaluation and routine testing in
medical imaging departments - Part
3-5: Acceptance tests - Imaging
61223-3-5 First
01/30/2014 12-270 IEC performance of computed
Edition 2004-08
tomography X-ray equipment
[Including: Technical Corrigendum 1
(2006)]
Evaluation and routine testing in
medical imaging departments - Part
3-5: Acceptance tests - Imaging
61223-3-5 Edition
12/23/2019 12-328 IEC performance of computed
2.0 2019-09
tomography X-ray equipment
[Including: Technical Corrigendum 1
(2006)]
Medical Electrical Equipment - Part
2-28: Particular Requirements For
60601-2-28 Edition
06/07/2018 12-309 IEC The Basic Safety And Essential
3.0 2017-06
Performance Of X-Ray Tube
Assemblies For Medical Diagnosis
Medical electrical equipment -
06/27/2016 12-299 IEC 62563-1 Edition 1.1 Medical image display systems - Part
1: Evaluation methods
Table 08: General Use Consensus Standards
Standard
Standard
Designation
Developing Title of Standard How was Standard Used
Number and
Organization
Date
Medical electrical
equipment - part 1: general Covered by ANSI AAMI ES60601-
60601-
IEC requirements for basic 1:2005/(R)2012 and A1:2012 as part of
1:2005+A1:2012
safety and essential EMC testing.
performance
Conformity Assessment –
Supplier’s declaration of Declaration of conformance to FDA
IEC/ISO 17050-1
conformity – Part 1: recognized consensus standards.
General requirements
Conformity assessment –
Supplier’s declaration of General consensus standards not
IEC/ISO 17050-2
conformity – Part 2: currently recognized by FDA.
Supporting documentation.

A list of applicable guidance documents considered for this submission is provided as Table 09
below.

Table 09: FDA Guidance Document and Effective Date

Guidance for Industry and FDA Staff – User Fees and Refunds for Premarket Notification
1. Submissions 510(k)
Document issued on October 2, 2017
Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy for 510(k)s
2.
Document issued on February 21, 2019
Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s - Guidance for
3. Industry and FDA Staff
Document issued on August 12, 2005
Guidance for Industry and FDA Staff: Deciding when to submit a 510(k) for a change to an existing
4. device.
Document issued on October 25, 2017
Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating
5. Substantial Equivalence in Premarket Notifications [510(k)]
Document Issued on July 28, 2014
Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submission for
6. Software in Medical Devices
Document issued on May 11, 2005
Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use in Medical Devices
7.
Document issued on September 9, 1999
Guidance for Industry and FDA Staff: Applying Human Factors and Usability
8. Engineering to Medical Devices.
Document issued February 3, 2016
Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging
9. Device Premarket Notifications.
Document issued on November 28, 2017
Guidance for Industry and FDA Staff: Content of Premarket Submissions for
10. Management of Cybersecurity in Medical devices.
Document issued on October 2, 2014
Guidance for Industry and FDA Staff: Information to Support a Claim of
11. Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices
Document issued on July 11, 2016
Guidance for Industry and Food Drug Administration Staff: Design considerations and Pre-Market
12. Submission recommendations for Interoperable Medical devices
Document Issued on September 6, 2017
Guidance for Industry and Food Drug Administration Staff:
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical
13.
Devices
Document issued on September 14, 2018
Verification and Validation
Software documentation for a moderate level of concern software per FDA’s Guidance Document
“Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”
issued on May 11, 2005 is also included as part of this submission. The Risk Analysis was completed,
and risk control implemented to mitigate identified hazards. The testing supports that all software
specifications have met the acceptance criteria. Testing for verification and validation support the
claims of substantial equivalence.

Siemens conforms to the Cybersecurity requirements by implementing a process of preventing

unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information
that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity
information in accordance with guidance document “Content of Premarket Submissions for
Management of Cybersecurity Medical Devices issues on October 2, 2014” is included within this
submission.
Additionally, Siemens conforms to the requirements for Radio Frequency Wireless Technology as
defined in FDA guidance document “Radio Frequency Wireless Technology in Medical Devices,
Guidance for Industry and Food and Drug Administration Staff, issued on August 14, 2013” by
adhering to the EMC and risk-based verification and validation requirements in design, testing, and
labeling of the wireless remote control components of the subject devices.
The Radio Frequency Wireless Technology of the optional Remote Scan Control and supporting
Control Device iPad for Scan&GO complies to 47 CFR part 15 subpart c – Intentional Radiators. All
Radio device labels will show an FCC ID code to show compliance. Shielding requirement applicable
to the NAEOTOM Alpha and respective Scatter Radiation diagrams for typical room installations are
provided in the User Documentation and Planning Guide of the intended Scanners in accordance with
IEC60601-2-44.
Wireless Coexistence Testing
Siemens has considered several measures to address wireless coexistence by design to ensure the
safe operation of the wireless components in combination with the applicable system supported
functionality. Wireless technology in the system setup to perform a task in a given shared
environment where other systems have an ability to perform their tasks and may or may not be using
the same set of rules has been considered. According to FDA guidance ‘Radio Frequency Wireless
Technology in Medical Devices” Siemens has addressed the safety, effectiveness, and high likelihood
of coexistence with other devices of this technology in our product design by our Risk Management
Process, Failure Mode and Effects Analysis (FMEA) Process, and Requirement Engineering Process.
As part of the risk management process, hazardous situations associated with the Scan&GO and its
connection to the host system via Wi-Fi were addressed as part of the Risk Management process.

Testing for co-existence considered for following scenarios:

• Co-Channel Testing
• Adjacent Channel Testing
• RF Interference Testing
• Separation Distance/Location Testing

Scan&GO is designed to allow dynamic frequency selection and transmission power control by
default in accordance with IEEE 802.11h. Adjacent channel testing is addressed by the fact that
Scan&GO does not support shared medium access to Siemens Wi-Fi network. RF interference was
tested by successfully ensuring that wireless communications were actively transmitting in situations
where possible interference may exist. Recommended distance and router locations requirements are
documented in the user documentation.

Summary
The features described in this premarket notification are supported with verification and validation
testing, dosimetry and imaging performance, and analysis of phantom images to assess device and
feature performance during product development. The risk analysis was completed, and risk control
implemented to mitigate identified hazards. The test results show that all of the software specifications
have met the acceptance criteria. Verification and validation testing of the device was found
acceptable to support the claim of substantial equivalence.
General Safety and Effectiveness Concerns
The device labeling contains instructions for use as well as necessary cautions and warnings to
provide for safe and effective use of the device. Risk management is ensured via a system related
risk analysis, which is used to identify potential hazards. These potential hazards are controlled during
development, verification and validation testing according to the risk management process. In order to
minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and
established industry practice and standards.

VIII. Conclusions
The predicate devices were cleared based on the results of non-clinical testing including verification
and validation, phantom tests, and supportive literature. The subject device is also tested using the
same test methods and workflows as used for the predicate devices. The non-clinical data supports
the safety of the device and the hardware and software verification and validation demonstrates that
the NAEOTOM Alpha should perform as intended in the specified use conditions. The data included
in this submission demonstrates that the NAEOTOM Alpha with described modifications performs
comparably to the predicate devices currently marketed for the same intended use. Since the subject
and predicate devices were tested using the same methods, Siemens believes that the data
generated from the NAEOTOM Alpha testing supports a finding of substantial equivalence.