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Recognized Consensus Standards
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Recognition List Number: 021 Publication Date: 03/18/2009 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 12-66: AIUM MUS, Medical Ultrasound Safety. (Radiology)

Date of Standard: 1994, Reaffirmed 2002. 
Address of Standards Organization:
  American Institute of Ultrasound in Medicine (AIUM)
  14750 Sweitzer Lane
  Suite 100
  Laurel, MD 20707
 
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Ultrasonic Pulsed Doppler Imaging Systems, Ultrasonic Pulsed Echo Imaging Systems
Processes Affected:
510(k)
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard and any annexes, requires addition of device specific information
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 System, Imaging, Pulsed Echo, Ultrasonic Class 2 IYO
 
Relevant Guidance:
Guidance for Industry and FDA Staff Information for Manufacterers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Document issued on: September 9, 2008
FDA Technical Contact:
  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
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