
Canon Medical Systems Corporation
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Aquilion ServeSP (TSX-307B) V2.0 is an FDA 510(k)-cleared medical device (K260078) manufactured by Canon Medical Systems Corporation. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 12, 2026. Regulation: 8.

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