VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000

VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000 is an FDA 510(k)-cleared medical device (K901602) manufactured by Resonex, 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 May 6, 1990. Regulation: 8.