T-SCAN 2000
FDA premarket approval P970033 · decided 1999-04-16
Approval details
- PMA number
- P970033
- Trade name
- T-SCAN 2000
- Generic name
- Imager, breast, electrical impedance
- Applicant
- Mirabel Medical Systems, Inc.
- Date received
- 1997-07-16
- Decision date
- 1999-04-16
- Days to decision
- 639 days
- Decision code
- APPR
- Product code
- NCL
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Austin, TX
- 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.
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