
GE Medical Systems SCS
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INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP is an FDA 510(k)-cleared medical device (K092639) manufactured by GE Medical Systems SCS. 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 1, 2009. Regulation: 8.