CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL

CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL is an FDA 510(k)-cleared medical device (K973833) manufactured by Dynarad 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 December 29, 1997. Regulation: 8.