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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 WITH L12-5 SCANHEAD
Generic NameSystem, imaging, pulsed doppler, ultrasonic
Regulation Number892.1550
ApplicantADVANCED TECHNOLOGY LABORATORIES, INC.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003
BOTHELL, WA 98041-3003
PMA NumberP940005
Supplement NumberS002
Date Received05/30/1997
Decision Date07/21/1998
Withdrawal Date 05/04/2009
Product Code IYN 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for design change from HDI 3000(R) Ultrasound System with L10-5 Scanhead to HDI 3000(R) Ultrasound System with L12-5 Scanhead for the indication of an adjunct o mammography and physical breast examination, to provide a high degree of physician confidence in differentiating benign from malignant or suspicious breast lesions. This device provides the physician with additional information to guide a biopsy decision. Utlity of this system has been demonstrated for lesions with an indeterminate Level of Suspicion (LOS 2-4) by conventional diagnostic modalities. Using the HDI system in the evaluation of solid mass characteristics can reduce the number of biopsies perofrmed on indeterminate lesions.
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