Faxitron VisionCT

Faxitron VisionCT is an FDA 510(k)-cleared medical device (K173309) manufactured by Faxitron Bioptics, 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 May 8, 2018. Regulation: 8.