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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.
Classification Namesystem, imaging, pulsed doppler, ultrasonic
Generic Nameultrasound breast imaging
Regulation Number892.1550
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.