
Toshiba America Medical Systems, In.C
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AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM is an FDA 510(k)-cleared medical device (K072606) manufactured by Toshiba America Medical Systems, In.C. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 1, 2007. Regulation: 8.