SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS

SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS is an FDA 510(k)-cleared medical device (K052042) manufactured by Sonoscape Company Limited. 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 8, 2005. Regulation: 8.