PRONOSCO X-POSURE SYSTEM

PRONOSCO X-POSURE SYSTEM is an FDA 510(k)-cleared medical device (K984178) manufactured by Torsana Osteoporosis Diagnostics A/S. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 17, 1999. Regulation: 8.