WORKSTATIONONE BREAST IMAGING WORKSTATION

WORKSTATIONONE BREAST IMAGING WORKSTATION is an FDA 510(k)-cleared medical device (K073272) manufactured by Three Palm Software, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 10, 2007. Regulation: 8.