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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 026 Date of Entry 03/14/2011 
FR Recognition Number 12-225
Computed Tomography Dose Check
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.
Transition Period
FDA recognition of NEMA XR 25-2010 [12-225] will be superseded by recognition of NEMA XR 25-2019 [Rec# 12-325]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-225] until January 23, 2022. After this transition period, declarations of conformity to [Rec# 12-225] will not be accepted.
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
 Rongping Zeng
Standards Development Organization
NEMA National Electrical Manufacturers Association https://www.nema.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.