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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.
Classification Namesystem, imaging, pulsed doppler, ultrasonic
Generic Namesystem, imaging, pulsed doppler, ultrasonic
Regulation Number892.1550
22100 bothell everett hwy.
p.o. box 3003
bothell, WA 98041-3003
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/material
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.