NEWTOM VGI AND NEWTOM 5G

NEWTOM VGI AND NEWTOM 5G is an FDA 510(k)-cleared medical device (K130442) manufactured by Qr S.R.L.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 2, 2013. Regulation: 8.