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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 027 FR Publication Date: 08/02/2011 

Part B: Supplementary Information

Recognition Number 12-230: NEMA XR 24-2008, primary user controls for interventional angiography x-ray equipment. (Radiology)

Date of Standard: 2008. 
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)
(3)OFFICE OF COMPLIANCE (OC)
Devices Affected:
Interventional fluroscopy equipment
Processes Affected:
510(k), QSR
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§892.1650 System, X-Ray, Fluoroscopic, Image-Intensified Class 2 JAA
§892.1680 Solid State X-Ray Imager (Flat Panel/Digital Imager) Class 2 MQB
§892.1700 Generator, High-Voltage, X-Ray, Diagnostic Class 1 IZO
§892.1720 System, X-Ray, Mobile Class 2 IZL
FDA Technical Contact:
 Donald Miller, M.D., F.A.C.R.
  FDA/CDRH/OCER
  10903 New Hampshire Avenue Builiding 66, Room 4553
  Silver Spring MD 20993
  301/796-3299
  email: donald.miller@fda.hhs.gov
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