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.
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.
| Device | TS2000 |
| Classification Name | Imager, Breast, Electrical Impedance |
| Generic Name | Imager, Breast, Electrical Impedance |
| Applicant | MIRABEL MEDICAL SYSTEMS, INC. |
| Date Received | 1999-06-23 |
| Decision Date | 1999-11-15 |
| PMA | P970033 |
| Supplement | S001 |
| Product Code | NCL |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MIRABEL MEDICAL SYSTEMS, INC. 9020 North Capitol Of Texas Highway suite 250 austin, TX 78759 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970033 | Original Filing | |
| S002 | 1999-06-15 | Normal 180 Day Track |
| S001 | 1999-06-23 | Normal 180 Day Track |