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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 014 FR Publication Date: 03/31/2006 

Part B: Supplementary Information

Recognition Number 12-141: IEEE N42.13-2004, calibration and usage of "dose calibrator" ionization chambers for the assay of radionuclides. (Radiology)

Date of Standard: 2004. 
Address of Standards Development Organization:
 Institute of Electrical and Electronic Engineers (IEEE)
  345 East 47th Street
  New York, NY 10017
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Radionuclide Dose Calibrators
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
§892.1360 Calibrator, Dose, Radionuclide Class 2 KPT
Relevant Guidance:
Guidance for Industry-Guidance for the Submission of Premarket Notification for Radionuclide Dose Calibrators. Document Issued on November 20, 1998
FDA Technical Contact:
 John Chen
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room G302
  Silver Spring MD 20993
  301/796-6540
  email: john.chen@fda.hhs.gov
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