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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Entry 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
Transition Period
FDA recognition of IEC 60601-2-37 Edition 2.0: 2007 [Rec# 12-209] will be superseded by recognition of IEC 60601-2-37 Edition 2.1:2015 [Rec# 12-293]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 12-209] until December 31, 2018. After this transition period, declarations of conformity to [Rec # 12-209] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
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 FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

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/OC/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
*These are provided as examples and others may be applicable.
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