SECONDLOOK (SL) CAD
FDA premarket approval P010038/S013 · decided 2010-12-07
Approval details
- PMA number
- P010038
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SECONDLOOK (SL) CAD
- Generic name
- Analyzer, medical image
- Applicant
- Icad, Inc.
- Date received
- 2006-12-18
- Decision date
- 2010-12-07
- Days to decision
- 1450 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Nashua, NH
- Statement
- APPROVAL FOR THE SECONDLOOK V7.2 CAD SYSTEM.
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