REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A

REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A is an FDA 510(k)-cleared medical device (K950972) 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 April 14, 1996. Regulation: 8.