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Recognized Consensus Standards
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Recognition List Number: 028 Publication Date: 03/16/2012 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 12-244: IEC 62359 (Second edition 2010) March 2011, Ultrasonics - Field charactization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields Corrigendum 1. (Radiology)

Date of Standard: 2011. 
Address of Standards Organization:
  International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
Non-fetal Ultrasound Monitor, Ultrasound pulsed Doppler Imaging System, Ultrasound Pulsed Echo Imaging System, Diagnostic Ultrasound Transducer
Processes Affected:
510(k)
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§892.1540 Monitor, Ultrasonic, Nonfetal Class 2 JAF
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§892.1550 System, Imaging, Pulsed Doppler, Ultrasonic Class 2 IYN
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§892.1560 System, Imaging, Pulsed Echo, Ultrasonic Class 2 IYO
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§892.1570 Media,Coupling,Ultrasound Class 2 MUI
§892.1570 Transducer, Ultrasonic, Diagnostic Class 2 ITX
 
Relevant Guidance:
Guidance for Industry and FDA Staff Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Document issued on: September 9, 2008
FDA Technical Contact:
  Gerald Harris
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 2104
  Silver Spring MD 20993
  301/796-2508
  Email: gerald.harris@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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