FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500

FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 is an FDA 510(k)-cleared medical device (K981404) manufactured by Fukuda Denshi USA, 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 May 19, 1998. Regulation: 8.