• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 038 Date of Entry 01/27/2015 
FR Recognition Number 12-287
Standard
NEMA XR 28-2013
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
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FDA recognition of NEMA XR 28-2013 [Rec# 12-287] will be superseded by recognition of NEMA Standards Publication XR 28-2018 [Rec# 12-330].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
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.
-
-