| 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. |
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| Device | T-SCAN 2000 |
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| Generic Name | Imager, breast, electrical impedance |
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| Applicant | MIRABEL MEDICAL SYSTEMS, INC.
9020 North Capitol of Texas Highway
Suite 250
Austin, TX 78759 |
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| PMA Number | P970033 |
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| Date Received | 07/16/1997 |
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| Decision Date | 04/16/1999 |
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| Product Code |
NCL |
| Docket Number | 99M-1073 |
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| Advisory Committee |
Radiology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 S002 |
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