SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5

SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5 is an FDA 510(k)-cleared medical device (K011315) 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 May 14, 2001. Regulation: 8.