DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111

DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111 is an FDA 510(k)-cleared medical device (K970813) manufactured by Denvu, 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 7, 1997. Regulation: 8.