SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096)

SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096) is an FDA 510(k)-cleared medical device (K944816) manufactured by Philips Medical Systems (Cleveland), 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 February 7, 1995. Regulation: 8.