Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

054

Date of Entry 07/06/2020 

FR Recognition Number

12-325

Standard

NEMA  Standards Publication XR 25 -2019
Computed Tomography Dose Check

Scope/Abstract

This standard applies to particular dose-related notification and alert messages appearing on the operating consoles of CT scanners.

This standard is not intended to define all notification, alert, or other messages resident on any CT scanner.

Extent of Recognition

Complete standard

Rationale for Recognition

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§892.1750	System, X-Ray, Tomography, Computed	Class 2	JAK

Relevant FDA Guidance and/or Supportive Publications*

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Laurel Burk   FDA/OC/CDRH/OPEQ/OIDRH/DRH/DXRS/   301-796-5933   laurel.burk@fda.hhs.gov

Rongping Zeng   FDA/OC/CDRH/OSEL/DIDSR/   301-796-2546   Rongping.Zeng@fda.hhs.gov

Standards Development Organization

NEMA National Electrical Manufacturers Association https://www.nema.org/

FDA Specialty Task Group (STG)

Radiology

*These are provided as examples and others may be applicable.