InVision™ 3T Recharge Operating Suite

InVision™ 3T Recharge Operating Suite is an FDA 510(k)-cleared medical device (K252239) manufactured by Imris Imaging, 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 5, 2025. Regulation: 8.