Avenda Health AI Prostate Cancer Planning Software

Avenda Health AI Prostate Cancer Planning Software is an FDA 510(k)-cleared medical device (K221624) manufactured by Avenda Health, 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 21, 2022. Regulation: 8.