X-RAY TV SYSTEM SONIAL VISION G4

X-RAY TV SYSTEM SONIAL VISION G4 is an FDA 510(k)-cleared medical device (K131075) manufactured by Shimadzu Corp.. 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 27, 2014. Regulation: 8.