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Recognition List Number: 022 Publication Date: 09/08/2009 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 12-198: IEC 60601-2-37 (2004) (2005) Amendment 2, 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: 2004. 
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 DEVICE EVALUATION (ODE)
Devices Affected:
Establishes particular requirements for the safety of ultrasonic diagnostic 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:
 International, Vertical
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
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§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
 
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:
  Bruce Herman
  FDA/CDRH/OSEL
  WO 62, Room 2214 10993 New Hampshire Avenue
  Silver Spring MD 20993
  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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