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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 056 Date of Entry 06/07/2021 
FR Recognition Number 12-337
Standard
NEMA NU 1-2018
Performance Measurements of Gamma Cameras
Scope/Abstract
This Standards Publication establishes definitions, quantitative measurements of performance characteristics, and reporting techniques for the specification of the following Gamma camera parameters
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FDA recognition of NEMA NU 1-2012 [Rec# 12-284] will be superseded by recognition of NEMA NU 1-2018 [Rec# 12-337].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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