TS2000
FDA premarket approval P970033/S001 · decided 1999-11-15
Approval details
- PMA number
- P970033
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Trade name
- TS2000
- Generic name
- Imager, breast, electrical impedance
- Applicant
- Mirabel Medical Systems, Inc.
- Date received
- 1999-06-23
- Decision date
- 1999-11-15
- Days to decision
- 145 days
- Decision code
- APPR
- Product code
- NCL
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Austin, TX
- 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 reco
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