Imbio Segmentation Editing Tool software

Imbio Segmentation Editing Tool software is an FDA 510(k)-cleared medical device (K180129) manufactured by Imbio, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 15, 2018. Regulation: 8.