DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM

DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM is an FDA 510(k)-cleared medical device (K883072) manufactured by Siemens Gammasonics, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 1988. Regulation: 8.