PLANMED SOPHIE & PLANMED SOPHIE CLASSIC

PLANMED SOPHIE & PLANMED SOPHIE CLASSIC is an FDA 510(k)-cleared medical device (K013656) manufactured by Planmed OY. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 15, 2002. Regulation: 8.