
Hitachi, Ltd., Power Systems Group
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PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM is an FDA 510(k)-cleared medical device (K073059) manufactured by Hitachi, Ltd., Power Systems Group. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 9, 2007. Regulation: 8.