HELIOS LASER IMAGER 1417

HELIOS LASER IMAGER 1417 is an FDA 510(k)-cleared medical device (K973028) manufactured by Sterling Diagnostic 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 October 27, 1997. Regulation: 8.