GyriCalc (Version 1.0.0)

GyriCalc (Version 1.0.0) is an FDA 510(k)-cleared medical device (K250686) manufactured by Neurospectrum Insights Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 21, 2025. Regulation: 8.