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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHDI 3000 ULTRASOUND SYSTEM
Classification Namesystem, imaging, pulsed doppler, ultrasonic
Generic Nameultrasound breast imaging
Regulation Number892.1550
ApplicantADVANCED TECHNOLOGY LABORATORIES, INC.
PMA NumberP940005
Supplement NumberS001
Date Received07/25/1996
Decision Date12/23/1996
Product Code
IYN[ Registered Establishments with IYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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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