• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

New Search Back To Search Results
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)OFFICE OF COMMUNICATION EDUCATION AND RADIATION PROGRAM (OCER)
DIVISION OF MAMMOGRAPHY QUALITY AND RADIATION PROGRAMS (DMQRP)
(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
-
-