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Reflexion Medical, Inc.
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RefleXion Medical Radiotherapy System (RMRS) is an FDA 510(k)-cleared medical device (DEN220014) manufactured by Reflexion Medical, 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 January 31, 2023. Regulation: 8.