M-VU ALGOIRITHM ENGINE
FDA premarket approval P100005/S001 · decided 2012-10-01
Approval details
- PMA number
- P100005
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- M-VU ALGOIRITHM ENGINE
- Generic name
- Analyzer, medical image
- Applicant
- Icad, Inc.
- Date received
- 2012-05-21
- Decision date
- 2012-10-01
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Nashua, NH
- Statement
- APPROVAL FOR ALGORITHM UPDATES AND THE EXPANSION TO MULTIPLE MAMMOGRAPHY SYSTEMS.
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