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Product Classification

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13/02/2024, 13:50 Product Classification

FDA Home3 Medical Devices4 Databases5


Product Classification
New Search Back to Search Results

Device Assembly, Tube Housing, X-Ray, Diagnostic


Regulation Description Diagnostic x-ray tube housing assembly.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product Code ITY
Premarket Review Office of Radiological Health6 (OHT8)
Division of Imaging Devices and Electronic Products (DHT8B)
Submission Type 510(K) Exempt
Regulation Number 892.17607
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report8
GMP Exempt? No
Summary Malfunction
Eligible
Reporting
Note: FDA has exempted almost all class I devices (with the exception of reserved devices9)
from the premarket notification requirement, including those devices that were exempted by final
regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is
important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-89210.
Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-
892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21
CFR Parts 862-89211, a premarket notification application and fda clearance is not required before
marketing the device in the U.S. however, these manufacturers are required to register their
establishment. Please see the Device Registration and Listing website12 for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
12-6 IEC 60806 First edition 1984-01
Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for
medical diagnosis13
12-309 IEC 60601-2-28 Edition 3.0 2017-06
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and
essential performance of X-ray tube assemblies for medical diagnosis14
12-348 IEC 60601-2-54 Edition 2.0 2022-09
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and
essential performance of X-ray equipment for radiography and radioscopy15
12-350 IEC 60806 Edition 2.0 2022-11
Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray
source assemblies for medical diagnosis16
Third Party Review Not Third Party Eligible

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13/02/2024, 13:50 Product Classification

3. https://www.fda.gov/
4. https://www.fda.gov/Medical-Devices
5. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/medical-device-databases
6. https://www.fda.gov/about-fda/cdrh-offices/cdrh-management-directory-
organization#OHT8
7. /scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=892.1760
8. /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=5606
9. /scripts/cdrh/cfdocs/cfpcd/3151.cfm
10. /scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpartfrom=862&cfrpartto=892
11. /scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpartfrom=862&cfrpartto=892
12. https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-
registration-and-listing
13. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=44270
14. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=40270
15. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=44832
16. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=44269

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2. http://www.addthis.com/bookmark.php
3. https://www.fda.gov/
4. https://www.fda.gov/Medical-Devices
5. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/medical-device-databases
6. https://www.fda.gov/about-fda/cdrh-offices/cdrh-management-directory-
organization#OHT8
7. /scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=892.1760

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8. /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=5606
9. /scripts/cdrh/cfdocs/cfpcd/3151.cfm
10. /scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpartfrom=862&cfrpartto=892
11. /scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpartfrom=862&cfrpartto=892
12. https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-
registration-and-listing
13. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=44270
14. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=40270
15. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=44832
16. /scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=44269

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