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Recognized Consensus Standards

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

Part B: Supplementary Information

Recognition Number 12-229: IEC PAS 61910-1 First Edition 2007-07, medical electrical equipment - radiation dose documentation - part 1: equipment for radiography and radioscopy. (Radiology)

Date of Standard: 2007. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
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:
Equipment for performing radiography and fluoroscopy; excluding equipment for performing: dental radiography and fluoroscopy, mammography, computed tomography
Processes Affected:
510(k), QSR
Type of Standard:
 Horizontal, International
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 Contacts:
 Stanley H. Stern
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 4538
  Silver Spring MD 20993
  301/796-5894
  email: stanley.stern@fda.hhs.gov
 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
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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