NEWTOM 3G QR-DVT 9000

NEWTOM 3G QR-DVT 9000 is an FDA 510(k)-cleared medical device (K041137) manufactured by Aperio Services, 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 May 13, 2004. Regulation: 8.