Aquilion ServeSP (TSX-307B) V2.0

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.