SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF

SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF is an FDA 510(k)-cleared medical device (K901422) manufactured by Image Systems, 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 August 20, 1990. Regulation: 8.