HD-IVUS ULTRASOUND IMAGING SYSTEM

HD-IVUS ULTRASOUND IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K112997) manufactured by Silicon Vally Medical 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 December 16, 2011. Regulation: 8.