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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 038 Date of Entry 01/27/2015 
FR Recognition Number 12-284
Standard
NEMA NU 1-2012
Performance Measurements of Gamma Cameras
Scope/Abstract
Provides a uniform criterion for the measurement and reporting of gamma camera performance parameters for single and multiple crystal cameras and tomographic devices that image a section or reconstruction image volume, or both.
Extent of Recognition
Complete standard
Transition Period
FDA recognition of NEMA NU 1-2012 [Rec# 12-284] will be superseded by recognition of NEMA NU 1-2018 [Rec# 12-337]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 12-284] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 12-284] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1100 Camera, Scintillation (Gamma) Class 1 IYX
FDA Technical Contact
 S. Andrew Kang
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/NMRTB/
  301-796-6544
  s.kang@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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