PMA P970033S001
- Device
- TS2000
- Applicant
- Mirabel Medical Systems, Inc.
- PMA number
- P970033
- Supplement
- S001
- Product code
- NCL
- Decision date
- 1999-11-15
- Classification
- Imager, Breast, Electrical Impedance
- Generic name
- Imager, breast, electrical impedance
- Approval order statement
- 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.
Current openFDA PMA Record#
- Device
- TS2000
- Applicant
- Mirabel Medical Systems, Inc.
- PMA number
- P970033
- Supplement
- S001
- Product code
- NCL
- Generic name
- Imager, breast, electrical impedance
- Decision date
- 1999-11-15
- Decision code
- APPR
- Date received
- 1999-06-23
- Supplement type
- Normal 180 Day Track
- Approval order statement
- 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.