SIS-300(N)-DIA SCAN

SIS-300(N)-DIA SCAN is an FDA 510(k)-cleared medical device (K926434) manufactured by Micro-Focus 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 17, 1993. Regulation: 8.