MAMMOGRAPHY CAD ENGINE
FDA premarket approval P030007/S001 · decided 2005-09-16
Approval details
- PMA number
- P030007
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MAMMOGRAPHY CAD ENGINE
- Generic name
- Analyzer, medical image
- Applicant
- Carestream Health, Inc.
- Date received
- 2005-07-05
- Decision date
- 2005-09-16
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR MINOR UPDATED TO THE COMPUTER-ASSISTED DETECTION ALGORITHMS.
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