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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 NameTS2000
Classification Nameimager, breast, electrical impedance
ApplicantMIRABEL MEDICAL SYSTEMS, INC.
PMA NumberP970033
Supplement NumberS001
Date Received06/23/1999
Decision Date11/15/1999
Product Code
NCL
Advisory Committee Radiology
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in the electronic circuitry, elimination of all but the 200 hz frequency, optional small probe, and optional phantom. The device is intended for use as an adjunct to mammography in patients who have equivocal mammographic findings within acr bi-rads(tm) categories 3 or 4. In particular, it is not intended for use in cases with clear mammographic or non-mammographic indications for biopsy. This device provides the radiologist with additional information to guide a biopsy recommendation.
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