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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceT-SCAN 2000
Classification Nameimager, breast, electrical impedance
Generic Nameimager, breast, electrical impedance
Applicant
MIRABEL MEDICAL SYSTEMS, INC.
9020 north capitol of texas highway
suite 250
austin, TX 78759
PMA NumberP970033
Date Received07/16/1997
Decision Date04/16/1999
Product Code
NCL
Docket Number 99M-1073
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the TransScan T-Scan 2000. The device is intended for use as an adjunct to mammography in patients who have equivocal mammographic finding within ACR BI-RADS (TM) categories 3 or 4. In particular, it is nnot 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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 
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