SECONDLOOK DIGITAL V7.2 CAD
FDA premarket approval P010038/S016 · decided 2012-11-09
Approval details
- PMA number
- P010038
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SECONDLOOK DIGITAL V7.2 CAD
- Generic name
- Analyzer, medical image
- Applicant
- Icad, Inc.
- Date received
- 2012-08-10
- Decision date
- 2012-11-09
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Nashua, NH
- Statement
- APPROVAL FOR THE SECONDLOOK DIGITAL V7.2 CAD FOR USE WITH THE PHILIPS MICRODOSE FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM.
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