SUPRIA w/guideShot Option

SUPRIA w/guideShot Option is an FDA 510(k)-cleared medical device (K161748) manufactured by Hitachi Medical Systems 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.