UST-5522-7.5 & UST-5522L-7.5 INTRAOPERATIVE TRANS.

UST-5522-7.5 & UST-5522L-7.5 INTRAOPERATIVE TRANS. is an FDA 510(k)-cleared medical device (K925486) 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 February 11, 1993. Regulation: 8.