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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM
Classification Namesystem, imaging, pulsed doppler, ultrasonic
Generic Nameultrasound breast imaging
Regulation Number892.1550
ApplicantADVANCED TECHNOLOGY LABORATORIES, INC.
PMA NumberP940005
Date Received02/17/1994
Decision Date04/11/1996
Withdrawal Date 05/04/2009
Product Code
IYN[ Registered Establishments with IYN ]
Docket Number 96M-0450
Notice Date 11/29/1996
Advisory Committee Radiology
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the ultramark 9 high definition imaging (hdi) ultrasound system with l10-5 scanhead.
Supplements: S001 S002 
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