UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35

UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35 is an FDA 510(k)-cleared medical device (K922549) manufactured by Aloka Co., Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 20, 1992. Regulation: 8.