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Device
system, x-ray, tomography, computed
Regulation Description
Computed tomography x-ray system.
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Product Code
JAK
Premarket Review
Office of In Vitro Diagnostics and Radiological Health
(OIR)
Submission Type
510(k)
Regulation Number
892.1750
Device Class
2
Total Product Life Cycle (TPLC)
TPLC Product Code Report
GMP Exempt?
No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
12-225 NEMA XR 25
Computed Tomography Dose Check
12-226 IEC 61223-2-6 Second Edition 2006-11
Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment
12-270 IEC 61223-3-5 First edition 2004-08
Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)]
12-287 NEMA XR 28-2013
Supplemental Requirements for User Information and System Function Related to Dose in CT
12-292 IEEE Std 3333.2.1-2015
IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
12-300 NEMA PS 3.1 - 3.20 (2016)
Digital Imaging and Communications in Medicine (DICOM) Set
12-302 IEC 60601-2-44 Edition 3.2: 2016
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
12-325 NEMA Standards Publication XR 25 -2019
Computed Tomography Dose Check
12-328 IEC 61223-3-5 Edition 2.0 2019-09
Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)]
12-330 NEMA Standards Publication XR 28-2018
Supplemental Requirements for User Information and System Function Related to Dose in CT
Implanted Device?
No
Life-Sustain/Support Device?
No
Third Party Review
Eligible for
Accredited Persons Program
Accredited Persons
accelerated device approval services
center for measurement standards of industrial
global quality and regulatory services
regulatory technology services, llc
third party review group, llc
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