3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING

3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING is an FDA 510(k)-cleared medical device (K002807) manufactured by Acuson Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 30, 2000. Regulation: 8.