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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Recognition List Number: 020 Publication Date: 09/09/2008 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 12-181: NEMA NU 1-2007, Performance Measurements of Gamma Cameras. (Radiology)

Date of Standard: 2007. 
Address of Standards Organization:
  National Electrical Manufacturers Association (NEMA)
  1300 North 17th Street
  Suite 1847
  Rosslyn, VA 22209
 
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Gamma Cameras
Processes Affected:
510(k)
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard and any annexes
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§892.1100 Camera, Scintillation (Gamma) Class 1 IYX
 
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contact:
  Andrew Kang
  FDA/CDRH/ODE (HFZ-470)
  9200 CORPORATE BLVD, HFZ-470
  Rockville MD 20850
  240/276-3666
  Email: s.kang@fda.hhs.gov
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