DUFFUSION-WEIGHTED MR IMAGING PACKAGE

DUFFUSION-WEIGHTED MR IMAGING PACKAGE is an FDA 510(k)-cleared medical device (K974530) manufactured by Philips Medical Systems (Cleveland), 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 February 5, 1998. Regulation: 8.