SCRIBE(TM) DIAGNOSTIC IMAGING WORKSTATION

SCRIBE(TM) DIAGNOSTIC IMAGING WORKSTATION is an FDA 510(k)-cleared medical device (K945428) manufactured by Multi-Dimensional Imaging, 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 8, 1995. Regulation: 8.