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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameT-SCAN 2000
Classification Nameimager, breast, electrical impedance
Generic Namemulti-frequency impedence breast scanner
ApplicantMIRABEL MEDICAL SYSTEMS, INC.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 
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