SONY CINE VIDEO SYSTEM SME-3500

SONY CINE VIDEO SYSTEM SME-3500 is an FDA 510(k)-cleared medical device (K904447) manufactured by Sony Medical Electronics Co.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 16, 1990. Regulation: 8.