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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 Recognition 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
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§892.1100 Camera, Scintillation (Gamma) Class 1 IYX
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 S. Andrew Kang
  FDA/OMPT/CDRH/OIR/DRH/NMRT/
  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
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