1.5T EDGE AND 1.0T VISTA SYSTEMS

1.5T EDGE AND 1.0T VISTA SYSTEMS is an FDA 510(k)-cleared medical device (K931544) manufactured by Philips Medical Systems (Cleveland), 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 November 21, 1993. Regulation: 8.