ScreenDx— 510(k) K241891
Substantially EquivalentImvaria, Inc.
FDA 510(k) clearance K241891 for ScreenDx, Substantially Equivalent on 2025-01-10. Applicant: Imvaria, Inc.. Device class: 2.
Clearance details
- Applicant
- Imvaria, Inc.
- Product code
- Code QWO
- Device class
- Class 2
- Regulation
- 21 CFR 892.2085
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Berkeley, CA, US
Recent devices under product code QWO
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