RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS

RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS is an FDA 510(k)-cleared medical device (K083645) manufactured by 5 Star Medical, 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 February 23, 2009. Regulation: 8.