Fibresolve (with PCCP)

Fibresolve (with PCCP) is an FDA 510(k)-cleared medical device (K252041) manufactured by Imvaria, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 6, 2025. Regulation: 8.