I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5

I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 is an FDA 510(k)-cleared medical device (K093066) manufactured by Infimed, 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 March 15, 2010. Regulation: 8.