SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE

SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE is an FDA 510(k)-cleared medical device (K953250) manufactured by GE Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 25, 1996. Regulation: 8.