ESTEEM 1.5T MRI SYSTEM

ESTEEM 1.5T MRI SYSTEM is an FDA 510(k)-cleared medical device (K962677) manufactured by Elscint Mr, 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 September 19, 1996. Regulation: 8.