MODELS 190GE-64/191GE-64/192GE-64/193GE-64

MODELS 190GE-64/191GE-64/192GE-64/193GE-64 is an FDA 510(k)-cleared medical device (K914536) manufactured by Medical Advances, 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 26, 1991. Regulation: 8.