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.
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.
| Device | T-SCAN 2000 |
| Classification Name | Imager, Breast, Electrical Impedance |
| Generic Name | Imager, Breast, Electrical Impedance |
| Applicant | MIRABEL MEDICAL SYSTEMS, INC. |
| Date Received | 1997-07-16 |
| Decision Date | 1999-04-16 |
| PMA | P970033 |
| Supplement | S |
| Product Code | NCL |
| Docket Number | 99M-1073 |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MIRABEL MEDICAL SYSTEMS, INC. 9020 North Capitol Of Texas Highway suite 250 austin, TX 78759 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970033 | Original Filing | |
| S002 | 1999-06-15 | Normal 180 Day Track |
| S001 | 1999-06-23 | Normal 180 Day Track |