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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHDI 3000 ULTRASOUND SYSTEM
Generic NameSystem, imaging, pulsed doppler, ultrasonic
Regulation Number892.1550
ApplicantAdvanced Technology Laboratories, Inc.
22100 Bothell Everett Hwy.
P.O. Box 3003
Bothell, WA 98041
PMA NumberP940005
Supplement NumberS001
Date Received07/25/1996
Decision Date12/23/1996
Withdrawal Date05/04/2009
Product Code IYN 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A DESIGN CHANGE FROM THE ULTRAMARK(R) 9 ULTRASOUND SYSTEM WITH HIGH DEFINITION(TM) IMAGING (HDI(TM)) AND L10-5 SCANHEAD TO A HDI 3000(R) ULTRASOUND SYSTEM WITH L10-5 SCANHEAD FOR THE INDICATION OF AN ADJUNCT TO MAMMOGRAPHY AND PHYSICAL BREAST EXAMINATION, TO PROVIDE A HIGH DEGREE OF PHYSICIAN CONFIDENCE IN DIFFERENTIATING BENIGN FROM MALIGNANT OR SUSPICIOUS BREAST LESIONS.
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