Imbio PHA (4.0.0)

Imbio PHA (4.0.0) is an FDA 510(k)-cleared medical device (K241847) manufactured by Imbio, 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 August 29, 2024. Regulation: 8.