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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 028 FR Publication Date: 03/16/2012 

Part B: Supplementary Information

Recognition Number 12-105: NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3. (Radiology)

Date of Standard: 2004. 
Address of Standards Development Organization:
 National Electrical Manufacturers Association (NEMA)
  1300 North 17th Street
  Suite 1847
  Rosslyn, VA 22209
 
CDRH Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
Non-Fetal Ultrasonic Monitor, Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo Imaging System, Diagnostic Ultrasound Transducer, Bone Sonometer
Processes Affected:
510(K), PMA
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard and any annexes
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§892.1540 Monitor, Ultrasonic, Nonfetal Class 2 JAF
§892.1550 System, Imaging, Pulsed Doppler, Ultrasonic Class 2 IYN
§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 Document issued on: September 9, 2008
FDA Technical Contacts:
 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
 Lauren N. Hefner
  FDA/CDRH/OIVD
  10903 New Hampshire Avenue Building 66, Room G312
  Silver Spring MD 20993
  301/796-6881
  email: lauren.hefner@fda.hhs.gov
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