Cirrus Resting State fMRI Software

Cirrus Resting State fMRI Software is an FDA 510(k)-cleared medical device (K251009) manufactured by Sora Neuroscience, 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 June 5, 2025. Regulation: 8.