Product Classification

• 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