SECONDLOOK DIGITAL
FDA premarket approval P010038/S017 · decided 2013-06-19
Approval details
- PMA number
- P010038
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SECONDLOOK DIGITAL
- Generic name
- Analyzer, medical image
- Applicant
- Icad, Inc.
- Date received
- 2012-10-05
- Decision date
- 2013-06-19
- Days to decision
- 257 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Nashua, NH
- Statement
- APPROVAL OF SECONDLOOK V7.2 CAD FOR USE WITH THE FUJI ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM
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| ProFound AI Software V2.1 (K191994) | Icad, Inc. | 2019-10-04 |
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| PowerLook Density Assessment Software (K180125) | Icad, Inc. | 2018-04-05 |
| Axxent Electronic Brachytherapy System Model 110 XP 1200 (K153570) | Icad, Inc. | 2016-02-25 |
| AXXENT CERVICAL APPLICATOR (K141343) | Icad, Inc. | 2014-09-05 |