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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 12-209: IEC 60601-2-37 Edition 2.0 2007-08, medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. (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 Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
Establishes particular requirements for the safety of ultrasonic equipment and those aspects there of which are directly related to safety. Does not cover ultrasonic therapeutic equipment; however, equipment used for the imaging of body structures by ultrasound in conjunction with therapeutic modalities is covered.
Processes Affected:
510(k)
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard and any annexes.

Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§892.1550 System, Imaging, Pulsed Doppler, Ultrasonic Class 2 IYN
§892.1560 Biopsy Needle Guide Kit Class 2 OIJ
§892.1560 System, Imaging, Optical Coherence Tomography (Oct) Class 2 NQQ
§892.1560 System, Imaging, Pulsed Echo, Ultrasonic Class 2 IYO
§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 Documents issued on: September 9, 2008
FDA Technical Contact:
 Bruce Herman
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 2204
  Silver Spring MD 20903
  301/796-2521
  email: bruce.herman@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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