ScreenDx— 510(k) K241891

Substantially Equivalent

Imvaria, Inc.

FDA 510(k) clearance K241891 for ScreenDx, Substantially Equivalent on 2025-01-10. Applicant: Imvaria, Inc..

Clearance details

Applicant: Imvaria, Inc.
Product code: Code QWO
Advisory panel: Radiology
Date received: 2024-06-28
Decision date: 2025-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkeley, CA, US

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