UST-5550-R; UST-5536-R; L43K

UST-5550-R; UST-5536-R; L43K is an FDA 510(k)-cleared medical device (K152126) manufactured by Hitachi Aloka Medical America, 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 August 16, 2016. Regulation: 8.