ProFound AI Software V3.0— 510(k) K203822
Substantially EquivalentIcad, Inc.
FDA 510(k) clearance K203822 for ProFound AI Software V3.0, Substantially Equivalent on 2021-03-12. Applicant: Icad, Inc.. Device class: 2.
Clearance details
- Applicant
- Icad, Inc.
- Product code
- Code QDQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2090
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Nashua, NH, US
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