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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 026 FR Publication Date: 03/18/2011 

Part B: Supplementary Information

Recognition Number 12-225: NEMA XR 25, computed tomography dose check. (Radiology)

Date of Standard: 2010. 
Address of Standards Development Organization:
 National Electrical Manufacturers Association (NEMA)
  1300 North 17th Street
  Suite 1847
  Rosslyn, VA 22209
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
(2)
(3)OFFICE OF COMPLIANCE (OC)
DIVISION OF ENFORCEMENT B (DOEB)
Devices Affected:
Computed Tomography Imaging Devices or Systems
Processes Affected:
510(k) Compliance
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§892.1750 System, X-Ray, Tomography, Computed Class 2 JAK
FDA Technical Contact:
 Kish Chakrabarti
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room G308
  Silver Spring MD 20993
  301/796-6539
  email: kish.chakrabarti@fda.hhs.gov
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