Faxitron Bioptics Speciemen Radiography System

Faxitron Bioptics Speciemen Radiography System is an FDA 510(k)-cleared medical device (K170786) 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 July 17, 2017. Regulation: 8.