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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 WITH L12-5 SCANHEAD
Classification Namesystem, imaging, pulsed doppler, ultrasonic
Generic Nameultrasound breast imaging
Regulation Number892.1550
ApplicantADVANCED TECHNOLOGY LABORATORIES, INC.
PMA NumberP940005
Supplement NumberS002
Date Received05/30/1997
Decision Date07/21/1998
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 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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