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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 12-330
Standard
NEMA Standards Publication XR 28-2018
Supplemental Requirements for User Information and System Function Related to Dose in CT
Scope/Abstract
Identifies uniform and standardized manufacturer's information provided to users of a CT scanner. This information includes perfusion scanning, use of Automatic Exposure Control, organization of dose-related information, a requirement for listing the reference protocols shipped on a CT system.
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FDA recognition of NEMA XR 28-2013 [Rec# 12-287] will be superseded by recognition of NEMA Standards Publication XR 28-2018 [Rec# 12-330]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 12-287] until July 9, 2023. After this transition period, declarations of conformity to [Rec# 12-287] 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
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 Contact
 Laurel Burk
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/DXRS/
  301-796-5933
  laurel.burk@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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