Philips Healthcare (Suzhou) Co., Ltd.

July 9, 2020
℅ Ms. Mary Zhu
Senior Regulatory Engineer
No. 258, Zhong Yuan Road, Suzhou Industrial Park
Suzhou, Jiangsu 215024
REPUBLIC OF CHINA

Re: K201640
Trade/Device Name: DuraDiagnost
Regulation Number: 21 CFR 892.1680
Regulation Name: Stationary x-ray system
Regulatory Class: Class II
Product Code: KPR, MQB
Dated: June 1, 2020
Received: June 16, 2020

Dear Ms. Zhu:

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# 04017.04.16
Silver Spring, MD 20993
www.fda.gov
K201640 – Ms. Mary Zhu 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,

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: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2020
Indications for Use See PRA Statement below.

510(k) Number (if known)

K201640

Device Name
DuraDiagnost

Indications for Use (Describe)

The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or
technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This
device is not intended for mammographic applications.

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

Prescription Use (Part 21 CFR 801 Subpart 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 OMB number.”

FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
 510(k) number: K201640
510(k) Summary

SPECIAL 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is prepared in accordance with
21 CFR §807.92.

Date Prepared: June 01, 2020

Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.
No. 258, ZhongYuan Road, Suzhou Industrial Park, 215024
Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF
CHINA
Establishment Registration Number: 3009529630
2nd manufacturing site:
Philips Medical Systems Nederland B.V.
Veenpluis 6, 5684PC Best, The Netherlands
Establishment Registration Number: 3003768277

Contact Person: Mary Zhu

Senior Regulatory Engineer
Phone: +86-021-24128746(cell: +86-183-5113-2881)
Fax: +86-512-68018677
E-mail: [email protected]

Device Name: DuraDiagnost

Classification: Classification Name Stationary X-Ray System
Classification Regulation: 21CFR §892.1680
Classification Panel: Radiology
Device Class: Class II
Primary product code: KPR (System, X-Ray,
Stationary)
Secondary code: MQB(21 CFR 892.1680)

Predicate Device: Trade Name: DuraDiagnost

Manufacturer: Philips Healthcare (Suzhou)
Co., Ltd.
510(k) Clearance: K141381-June 12, 2014
Classification Regulation: 21 CFR, Part 892.1680
Classification Name: Stationary X-Ray System
Classification Panel: Radiology
Device Class: Class II
Product Code KPR, MQB

Reference Device 1: Trade Name: MobileDiagnost WDR 2.2

Manufacturer: SEDECAL SA

DuraDiagnost Premarket Notification- Special 510(k)

Page 1 of 14
 510(k) Clearance: K191813- August 2, 2019
Classification Regulation: 21CFR 892.1720
Classification Name: Mobile x-ray system
Classification Panel: Radiology
Device Class: Class II
Product Code IZL, MQB

Reference Device 2: Trade Name: Philips Eleva Workspot with

SkyFlow
Manufacturer: Philips Medical Systems
DMC GmbH
510(k) Clearance: K153318- December 22, 2015
Classification Regulation: 21 CFR 892.1680
Classification Name: Stationary X-Ray System
Classification Panel: Radiology
Device Class: Class II
Product Code MQB, LLZ

Reference Device 3: Trade Name: DigitalDiagnost C90

Manufacturer: Philips Medical Systems
DMC GmbH
510(k) Clearance: K182973- January 11, 2019
Classification Regulation: 21CFR 892.1680
Classification Name: Stationary X-Ray System
Classification Panel: Radiology
Device Class: Class II
Product Code MQB, KPR, LLZ

Device description: The DuraDiagnost is a flexible digital radiography (DR)

system that is designed to provide fast and smooth
radiography examinations of sitting, standing or lying
patients.
The DuraDiagnost consist of the following components:
Tube column with X-ray assembly, wall stand with detector
carrier, patient table with detector carrier and floating table
top, high voltage generator, and acquisition and reviewing
workstation for post-processing, storage and viewing of
images. Images may be transferred via a DICOM network for
printing, storage and detailed review.

Indications for use: The DuraDiagnost is intended for use in generating

radiographic images of human anatomy by qualified/trained
doctor or technician. Applications can be performed with the

DuraDiagnost Premarket Notification- Special 510(k)

Page 2 of 14
 patient sitting, standing, or lying in the prone or supine
position. This device is not intended for mammographic
applications.

Fundamental scientific The fundamental scientific technology utilized in the

technology: DuraDiagnost and the currently marketed and predicate
DuraDiagnost (K141381, June 12, 2014) is equivalent with
regards to the functionality of the following components:
Integrated tube column, patient table with a floating table top,
high-voltage generator, dual-focus rotation anode X-Ray tube,
manual beam limiting device, digital detector, wall stand and
workstation for images post-processing, storage and viewing
(See Table 1 comparing the DuraDiagnost to the currently
marketed and predicate DuraDiagnost (K141381, June 12,
2014) provided below).

The outcome of this comparison demonstrates that the minor

differences in the technological characteristics do not affect
the safety or effectiveness of the DuraDiagnost when
compared to the currently marketed and predicate
DuraDiagnost (K141381, June 12, 2014).

The wireless portable detector of the DuraDiagnost is

identical to the wireless portable detector (SkyPlate E) of the
currently marketed and reference device 1, MobileDiagnost
WDR 2.2 (K191813- August 2, 2019) manufactured by
SEDECAL SA. Therefore, both the wireless portable detector
(Skyplate E) of the DuraDiagnost and the currently marketed
and reference device 1, MobileDiagnost WDR 2.2 employ
identical fundamental scientific technology.

The DuraDiagnost and the currently marketed and Reference

Device 3, DigitalDiagnost C90 (K182973- January 11, 2019)
manufactured by Philips Medical Systems DMC GmbH are
provided with identical; fixed RAD detector (Pixium
4343RCE),UNIQUE 2 Post Processing software and
embedded Windows 10 operating system. Therefore,
DuraDiagnost and the currently marketed and reference

DuraDiagnost Premarket Notification- Special 510(k)

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 device 3, DigitalDiagnost C90 employ identical fundamental
scientific technology.

Table 1
Comparison of Technological Characteristics of Currently marketed and Predicate DuraDiagnost versus
the DuraDiagnost
Feature Predicate Device: Device: Comment
DuraDiagnost DuraDiagnost
(K141381)
Basic information
Product Code KPR & MQB Identical No difference; thus,
demonstrating SE.
Regulation No. 21 CFR 892.1680 Identical No difference; thus,
demonstrating SE.
Device Class II Identical No difference; thus,
demonstrating SE.
Electrical Input voltage: 3- phase, Input voltage: 3- phase,
Equivalent. The
Requirement 200/208/240/380/40 200/208/240/380/40 DuraDiagnost and the
0/415/440/480/500V 0/415/440/480/500V currently marketed and
ac; ac; predicate DuraDiagnost are
Frequency:50/60Hz; Frequency:50/60Hz; both provided with similar
Current: Current: electrical requirements.
Short term: 112A (with Short term: 112A (with Therefore, no impact on the
safety or effectiveness of the
generator M-CABINET generator M-CABINET
device. Thus, demonstrating
CXA Pro 50kW), 134A CXA Pro 50kW), 134A SE.
(with generator M- (with generator M-
CABINET CXA Pro CABINET CXA Pro
65kW), 160A (with 65kW),
generator M-CABINET Long term: 10A.
CXA Pro
80kW);
Long term: 10A.
Design characteristic
X-ray Tube RO 1750 ROT 360 & Identical No difference; thus,
SRO 33100 ROT 360 demonstrating SE.
Max Tube 150kV Identical No difference; thus,
Voltage demonstrating SE.
Focal Spot Size 0.6mm/1.2mm Identical No difference; thus,
demonstrating SE.
Tube Max power 50KW/100KW Identical No difference; thus,
(250W equivalent anode demonstrating SE.
input power)
Anode Type Rotation Identical No difference; thus,
demonstrating SE.

DuraDiagnost Premarket Notification- Special 510(k)

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Generator Philips Healthcare Philips Healthcare
Equivalent. DuraDiagnost
(Suzhou), (Suzhou),
and the currently marketed
M-CABINET CXA Pro M-CABINET CXA Pro
and predicate DuraDiagnost
50kW, 50kW,
are both provided with
M-CABINET CXA Pro M-CABINET CXA Pro
65kW, 65kW, 50KW/65KW
M-CABINET CXA Pro generators.Thus,
80kW demonstrating SE.
Max Power 50KW/65KW/80KW 50KW/65KW
KV range 40-150 Identical No difference; thus,
demonstrating SE.
Milli ampere sec 0.4 mAs-600 mAs (with Identical No difference; thus,
(mAs) product AEC control) demonstrating SE.
Collimator
Operation Mode Manual collimation Identical No difference; thus,
demonstrating SE.
Shape of Beam Rectangular Identical No difference; thus,
demonstrating SE.
Detector
Type Digital Detector Identical No difference; thus,
 Fixed RAD Detector Demonstrating SE.
 Wireless Static
Detector

Fixed RAD Pixium 4343RG Pixium 4343RCE The difference between

Detector (Note: this detector is 4343RCE and 4343RG is
identical to fixed RAD scintillator material and other
detector of the currently minor differences of image
marketed and Reference area and image matrix as
Device 3, DigitalDiagnost compared in this table. The
C90 cleared under differences don’t affect the
K182973). safety or effectiveness.
And the fixed RAD detector
Pixium 4343RCE of the
DuraDiagnost is identical to
the fixed RAD detector of the
currently marketed and
Reference Device 3,
DigitalDiagnost
C90(K182973- January 11,
2019, Philips Medical
Systems DMC).
Thus, demonstrating SE
Wireless Static  SkyPlate Large  SkyPlate Large (Trixell The SkyPlate Large Detector
Detector (Trixell 3543EZ) 3543EZ) of the DuraDiagnost is
identical to the SkyPlate

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  SkyPlate E (Trixell Large Detector of the
3543DR) (Note: this currently marketed and
detector is identical to Predicate DuraDiagnost
the Skyplate E (K141381,
Detector of the
currently marketed and SkyPlate E is additionally
reference device 1, added dectector. There are
MobileDiagnost WDR minor differences between
2.2 cleared under SkyPlate E and the Skyplate
K191813). Large detector of image area,
image matrix and pixel size as
compared in this table. The
minor differences don’t affect
the safety or effectiveness.
And the Skyplate E Detector
of DuraDiagnost is identical
to the Skyplate E Detector of
the currently marketed and
reference device 1,
MobileDiagnost WDR 2.2
(K191813- August 2, 2019).

Thus, demonstrating SE
X-ray Scintillator  GdOS (Fixed: Pixium  Cesium Iodide (Fixed: The fixed RAD detector of
Material 4343RG) Pixium 4343RCE. the DuraDiagnost and
Pixium 4343RCE is currently marketed and
identical to fixed RAD Reference Device 3,
detector of the DigitalDiagnost
currently marketed and C90(K182973- January 11,
Reference Device 3, 2019, Philips Medical
DigitalDiagnost C90 Systems DMC) are both
cleared under K182973 fabricated from identical
) Cesium Iodide material , thus
demonstrating SE.
 Cesium Iodide  Cesium Iodide
(Wireless: SkyPlate (Wireless: SkyPlate The Wireless detector of the
Large) Large and SkyPlate E) DuraDiagnost and the
currently marketed and
predicate DuraDiagnost are
both fabricated from identical
Cesium Iodide material, thus
demonstrating SE.

Image Area  42.5cm x 42.5cm  42.03cm x The image area of the

(Fixed: Pixium 42.54cm(Fixed: DuraDiagnost, provided with
4343RG) Pixium 4343RCE) fixed RAD detector is

DuraDiagnost Premarket Notification- Special 510(k)

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  34.5cm x 42.1cm  34.5cm x identical to the image area of
(Wireless: SkyPlate 42.1cm(Wireless: the Fixed RAD Detector of
Large) SkyPlate Large) the currently marketed and
Reference Device 3,
 34.5cm x DigitalDiagnost
42.5cm(Wireless: C90(K182973- January 11,
SkyPlate E) 2019, Philips Medical
Systems DMC), thus
demonstrating substantial
equivalence

The image area of the

proposed DuraDiagnost,
provided with wireless
detector SkyPlate Large is
identical to the wireless
detector SkyPlate Large of the
currently marketed and
Predicate DuraDiagnost
(K141381). Thus,
demonstrating SE.

The image area of the

proposed Wireless Detector
SkyPlate E is identical to the
Wireless Detector SkyPlate E
of the currently marketed and
reference device 1,
MobileDiagnost WDR 2.2
(K191813- August 2, 2019,
Sedecal SA,). thus
demonstrating SE

Image Matrix  2,874 x 2,869 (Fixed:  2,874 x 2840 (Fixed: The image matrix of the
Pixium 4343RG) Pixium 4343RCE) proposed DuraDiagnost
Philips Medical Systems
 2330 x 2846  2330 x 2846 (Wireless- DMC, provided with fixed
(Wireless-SkyPlate SkyPlate Large) RAD detector is identical to
Large) the image matrix of the

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  2156 x 2653 (Wireless- currently marketed and
SkyPlate E) Reference Device 3,
DigitalDiagnost
C90(K182973- January 11,
2019,). thus demonstrating
substantial equivalence.

The image matrix of the

DuraDiagnost
provided with the wireless
SkyPlate Large Detector is
identical to the wireless
SkyPlate Large of the
currently marketed predicate
Device DuraDiagnost,
(K141381). Thus
demonstrating SE.

The image matrix of the

DuraDiagnost provided with
wireless detector SkyPlate E
is similar to the currently
marketed and Reference
Device 1, MobileDiagnost
WDR 2.2 (K191813- August
2, 2019, Sedecal SA).
Infinitesimal change in the
image size (X-ray field) does
not impact clinical Image
Quality. Therefore, they are
equivalent and there is no
impact on the safety and
effectiveness of the device;
thus, demonstrating SE.

DuraDiagnost Premarket Notification- Special 510(k)

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Pixel Size  148 μm (Fixed:  148 μm (Fixed: Pixium The pixel size of the proposed
Pixium 4343RG) 4343RCE) DuraDiagnost Philips Medical
Systems DMC, provided with
fixed RAD detector is
identical to the pixel size of
the currently marketed and
Reference Device 3,
DigitalDiagnost
C90(K182973- January 11,
2019,). thus demonstrating
substantial equivalence.

The pixel size of the

DuraDiagnost
provided with the wireless
SkyPlate Large Detector is
identical to the wireless
SkyPlate Large of the
currently marketed predicate
Device DuraDiagnost,
(K141381). Thus
demonstrating SE.

 148 μm(Wireless-  148 μm(Wireless- The pixel size of the

SkyPlate Large) SkyPlate Large) DuraDiagnost provided with
wireless detector SkyPlate E
 160 μm (Wireless-
is identical to the currently
SkyPlate E)
marketed and Reference
Device 1, MobileDiagnost
WDR 2.2 (K191813- August
2, 2019, Sedecal SA), thus
demonstrating SE.

Analog / Digital 16 bits Identical No difference; thus,

(A/D) conversion demonstrating SE.
Table
Table type Fixed and Height Height adjustment The DuraDiagnost is
adjustment provided with height
adjustment table that is also
provided with the currently
marketed and predicate

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 DuraDiagnost. Thus
demonstrating SE.
Height adjustment 51.5 cm to 75.0 cm above 51.5 cm to 91.5 cm above The height adjustment of the
floor, motorized floor, motorized adjustment proposed DuraDiagnost,
adjustment provided with height
adjustable table is identical to
the currently marketed and
Reference Device 3,
DigitalDiagnost
C90(K182973- January 11,
2019, Philips Medical
Systems DMC).
thus, demonstrating SE.
Tabletop +/- 550mm Identical No difference; thus,
longitudinal travel demonstrating SE.
range
Tabletop Lateral +/- 130mm Identical No difference; thus,
travel demonstrating SE.
Loading (patient 210 Kg Identical No difference; thus,
weight) demonstrating SE.
Wall Stand
Vertical movement 1500mm Identical No difference; thus,
range demonstrating SE.
Movement mode Manual Identical No difference; thus,
demonstrating SE..
Tube Stand
Type Floor mounted Identical No difference; thus,
demonstrating SE.
Tube rotation +/- 120 degree Identical No difference; thus,
demonstrating SE.
Longitudinal 1400mm Identical No difference; thus,
movement range demonstrating SE.
Source to Image Distance（SID）
SID Table: 40-115cm; Identical No difference; thus,
Wallstand: 110-245cm demonstrating SE.
External Connectivity
DICOM DICOM compatible Identical No difference; thus,
demonstrating SE.
Software Platform
Software Eleva WorkSpot Identical No difference; thus,
demonstrating SE.
SkyFlow Software No Yes The DuraDiagnost includes
the SkyFlow software that is
also used in the currently
marketed and Reference
Device 3, Eleva Workspot
with SkyFlow, (K153318-
December 22, 2015, Philips
Medical Systems DMC),
thus, demonstrating SE.
Image Processing UNIQUE UNIQUE 2 UNIQUE 2 image processing
Algorithm algorithm provided with
DuraDiagnost ., was

DuraDiagnost Premarket Notification- Special 510(k)

Page 10 of 14
 previously cleared with the
currently marketed and
Reference Device 3,
DigitalDiagnost C90
(K182973- January 11, 2019,
Philips Medical Systems
DMC).
Upgrading to UNIQUE2
image processing algorithm
does not alter the clinical
workflow, hence no impact on
the safety or effectiveness of
the device; thus,
demonstrating SE
Operating System Windows 7 embedded Windows 10 embedded Introduction of operating
system Windows 10
embedded does not impact
clinical image quality.
Therefore, there is no impact
on the safety and
effectiveness of the device;
thus, demonstrating SE.

Based on the information provided above, the

DuraDiagnost is considered substantially
equivalent to the currently marketed and predicate
DuraDiagnost (K141381, June 12, 2014) in terms of
fundamental scientific technology.
Summary of Non-Clinical This 510(k) premarket notification contains the technical
Performance data:
documentation, which demonstrates that the
DuraDiagnost is substantially equivalent to the currently
marketed and predicate DuraDiagnost (K141381, June
12, 2014). The technical documentation includes non-
clinical verification / validation tests. These tests were
performed on the DuraDiagnost according to the
following international and FDA-recognized consensus
standards:
 International and FDA-recognized consensus
standards:
 AAMI / ANSI ES60601-1: 2005/(R)2012 and
C1:2009/(R)2012 and, A2:2010/(R)2012
(consolidated text) Medical electrical equipment
–Part 1: General requirements for basic safety and
essential performance. (Edition 3.1). FDA/CDRH
recognition number 19-4.

DuraDiagnost Premarket Notification- Special 510(k)

Page 11 of 14
  IEC 60601-1-2, Medical electrical equipment –
Part 1-2: General requirements for basic safety
and essential performance – Collateral Standard:
Electromagnetic Disturbances – Requirements
and tests (Edition 4.0 2014). FDA/CDRH
recognition number 19-8.
 IEC 60601-1-3, Medical Electrical Equipment
Part 1-3: General Requirements for Basic Safety
and Essential Performance-Collateral Standard:
Radiation Protection in Diagnostic X-Ray
Equipment. (Edition 2.1 2013). FDA/CDRH
recognition number 12-269.
 IEC60601-2-28 Medical electrical equipment -
Part 2-28: Particular requirements for the basic
safety and essential performance of X-ray tube
assemblies for medical diagnosis, (Edition 2.0
2010-03). FDA/CDRH recognition number 12-
204.
 IEC 60601-2-54, Medical Electrical Equipment-
Part 2-54: Particular Requirements for the Basic
Safety and Essential Performance of X-Ray
Equipment for Radiography and Radioscopy
(Edition 1.1 2015). FDA/CDRH recognition
number 12-296.
 IEC 60601-1-6, Medical Electrical Equipment
Part 1-6: General Requirements for Basic Safety
and Essential Performance- Collateral Standard:
Usability (Edition 3.1 2013). FDA/CDRH
recognition number 5-89.
 IEC 62304 Medical device software - Software
life cycle processes (Edition 1.1 2015)
FDA/CDRH recognition number 13-79
 IEC 62366-1 Medical devices - Part 1:
Application of usability engineering to medical
devices (Edition 1.0 2015). FDA/CDRH
recognition number 5-114.
 ISO 14971 Medical devices – Application of risk
management to medical devices (Edition 2.0,
corrected version, 2007). FDA/CDRH
recognition number 5-40.
 CFR 1020.30 Diagnostic x-ray systems and their
major components.
 CFR 1020.31 Radiographic equipment.
 Device specific guidance document, entitled
“Guidance for the Submission of 510(k)s for Solid
State X-ray Imaging Devices – September 1, 2016”
DuraDiagnost Premarket Notification- Special 510(k)
Page 12 of 14
  FDA’s Guidance document entitled, “Guidance for the
Content of Premarket Submissions for Software
Contained in Medical Devices – May 11, 2005.”
 FDA’s Guidance document entitled, “Guidance for
Industry and FDA Staff – Content of Premarket
Submissions for Management of Cybersecurity in
Medical Devices” ,issued October 2, 2014
 Pediatric Information for X-ray Imaging Device
Premarket Notifications, issued November 28, 2017

Non-clinical verification and validation tests have been

performed with regards to the intended use, the technical
claims, requirement specifications, and the risk
management results.

Non-clinical verification and validation test results

demonstrate that DuraDiagnost:
 Complies with the aforementioned international
and FDA-recognized consensus standards and
FDA guidance documents.
 meets the acceptance criteria and is adequate for
its intended use.

Therefore, DuraDiagnost is substantially equivalent to

the currently marketed and predicate DuraDiagnost
(K141381, June 12, 2014) in terms of safety and
effectiveness.
Summary of Clinical Data: The DuraDiagnost does not require clinical study since
substantial equivalence to the primary currently marketed
and predicate device was demonstrated with the
following attributes:
 Indication for use;
 Fundamental scientific technology;
 Non-clinical performance testing; and
 Safety and effectiveness.

Furthermore, the SkyPlate E detector and Pixium

4343RCE detector utilizes the same design, technology
and Image acquisition workflow compared to the
previously Skyplate Large detector and Pixium 4343RG

DuraDiagnost Premarket Notification- Special 510(k)

Page 13 of 14
 detector used in the marketed and predicate
DuraDiagnost (K141381, June 12, 2014). All technical
detector characteristics that potentially have an influence
on image quality are assessed and verified according to
FDA Guidance for Industry and Food and Drug
Administration Staff: Guidance for the Submission of
510(k)’s for Solid State X-ray Imaging Devices; issued
on September 1, 2016.

Substantial Equivalence The DuraDiagnost is substantially equivalent to the

Conclusion: currently marketed and predicate DuraDiagnost
(K141381, June 12, 2014) in terms of design features,
fundamental scientific technology, indications for use,
and safety and effectiveness.

Additionally, substantial equivalence was demonstrated

with non-clinical performance (verification and
validation) tests, which complied with the requirements
specified in the international and FDA-recognized
consensus standards, ISO 14971, IEC 60601-1, IEC
60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-
1-6, IEC 60601-2-28, IEC 62304, and IEC 62366-1.

The results of these tests demonstrate that DuraDiagnost

met the acceptance criteria and is adequate for its
intended use.

DuraDiagnost Premarket Notification- Special 510(k)

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