ROCHE AXISCAN 5

ROCHE AXISCAN 5 is an FDA 510(k)-cleared medical device (K771816) manufactured by Roche Medical Electronics, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 18, 1977. Regulation: 8.