PRESTILIX 1694 D IMAGE INTENSIFIED FLUOROSCCOPIC

PRESTILIX 1694 D IMAGE INTENSIFIED FLUOROSCCOPIC is an FDA 510(k)-cleared medical device (K924310) manufactured by GE Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 20, 1993. Regulation: 8.