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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Recognition 06/27/2016 
FR Recognition Number 12-293
Standard
IEC 60601-2-37 Edition 2.1 2015
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§892.1570 Media, Coupling, Ultrasound Class 2 MUI
§892.1570 Transducer, Ultrasonic, Diagnostic Class 2 ITX
§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
§892.1550 System, Imaging, Pulsed Doppler, Ultrasonic Class 2 IYN
Relevant FDA Guidance and/or Supportive Publications
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
 Keith Wear
  FDA/OMPT/CDRH/OSEL/DAM/
  301-796-2538
  keith.wear@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Radiology
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