SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC

SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC is an FDA 510(k)-cleared medical device (K852331) manufactured by Scholten Surgical Instruments, 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 July 31, 1986. Regulation: 8.