FDI 2000 ULTRASONIC SKIN SCANNER

FDI 2000 ULTRASONIC SKIN SCANNER is an FDA 510(k)-cleared medical device (K902965) manufactured by Fulmer Dyson Intl.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 25, 1990. Regulation: 8.