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Recognized Consensus Standards

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

Part B: Supplementary Information

Recognition Number 12-193: AIUM AOL 2008, acoustic output labeling standard for diagnostic ultrasound equipment revision 1 - a standard for how manufacturers should specify acoustic output data. (Radiology)

Date of Standard: 2008. 
Address of Standards Development 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:
Non-fetal Ultrasound Monitor, Ultrasound pulsed Doppler Imaging System, Ultrasound Pulsed Echo Imaging System, Diagnostic Ultrasound Transducer
Processes Affected:
510(k)
Type of Standard:
 Vertical, National
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 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 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 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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