SuRgical Planner (SRP) BrainStorm

SuRgical Planner (SRP) BrainStorm is an FDA 510(k)-cleared medical device (K201465) manufactured by Surgical Theater, 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 July 16, 2020. Regulation: 8.