Fibresolve (with PCCP)— 510(k) K252041

Substantially Equivalent

Imvaria, Inc.

FDA 510(k) clearance K252041 for Fibresolve (with PCCP), Substantially Equivalent on 2025-11-07. Applicant: Imvaria, Inc..

Clearance details

Applicant: Imvaria, Inc.
Product code: Code QWO
Advisory panel: Radiology
Date received: 2025-06-30
Decision date: 2025-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkeley, CA, US

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