MySegmenter (v2.0.0)

MySegmenter (v2.0.0) is an FDA 510(k)-cleared medical device (K242647) manufactured by Mysegmenter Technologies, 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 April 15, 2025. Regulation: 8.