PowerLook Density Assessment V4.0— 510(k) K211506
Substantially EquivalentIcad, Inc.
FDA 510(k) clearance K211506 for PowerLook Density Assessment V4.0, Substantially Equivalent on 2021-07-12. Applicant: Icad, Inc.. Device class: 2.
Clearance details
- Applicant
- Icad, Inc.
- Product code
- Code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nashua, NH, US
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