IMAGECHECKER CAD
FDA premarket approval P970058/S025 · decided 2012-09-21
Approval details
- PMA number
- P970058
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMAGECHECKER CAD
- Generic name
- Analyzer, medical image
- Applicant
- Hologic, Inc.
- Date received
- 2012-02-06
- Decision date
- 2012-09-21
- Days to decision
- 228 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- APPROVAL FOR IMPROVEMENTS IN THE CAD ALGORITHM, UPDATED DIGITAL TEST DATABASE AND SUPPORT FOR GE SENOGRAPHE ESSENTIAL FFDM.
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