VirtuOst Vertebral Fracture Assessment

VirtuOst Vertebral Fracture Assessment is an FDA 510(k)-cleared medical device (K171435) manufactured by O.N. Diagnostics, 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 August 2, 2018. Regulation: 8.