CASS SYSTEM (MODIFICATION)

CASS SYSTEM (MODIFICATION) is an FDA 510(k)-cleared medical device (K961484) manufactured by Medical Instrumentation & Diagnostics Corp.(Midco). This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 6, 1996. Regulation: 8.