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Product Classification

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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

Submission Type

510(k)

Regulation Number

892.1750

Device Class

2

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Recognized Consensus Standards

IEC 60601-2-44 Edition 3.0 2009-02 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
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
IEC 61223-3-5 (First edition - 2004) Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment CORRIGENDUM 1
IEC 60601-2-44 (Third edition - 2009) Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography CORRIGENDUM 1
NEMA XR 25 Computed Tomography Dose Check
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
IEC 60601-2-44 Edition 3.0 2012-08 Amendment 1 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
NEMA PS 3.1 - 3.20 (2011) Digital Imaging and Communications in Medicine (DICOM) Set
NEMA XR7-1995 (R2000) High-Voltage X-Ray Cable Assemblies and Receptacles

Third Party Review

Eligible for Accredited Persons Program

Accredited Persons

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