DFI-1000 AND DVS-475 IMAGING DEVICES

DFI-1000 AND DVS-475 IMAGING DEVICES is an FDA 510(k)-cleared medical device (K951261) manufactured by Nical. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 14, 1996. Regulation: 8.