POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM

POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM is an FDA 510(k)-cleared medical device (K913120) manufactured by Siemens Medical Solutions USA, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 15, 1991. Regulation: 8.