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U.S. Department of Health and Human Services

Recognized Consensus Standards

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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
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.
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