
Hitachi Aloka Medical, Ltd.
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PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K123828) manufactured by Hitachi Aloka Medical, 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 January 17, 2013. Regulation: 8.

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