CONSULTIVA REPORT STATION, MODEL RS-1

CONSULTIVA REPORT STATION, MODEL RS-1 is an FDA 510(k)-cleared medical device (K031248) manufactured by Miramedica, 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 June 19, 2003. Regulation: 8.