
GE Healthcare
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4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ is an FDA 510(k)-cleared medical device (K101166) manufactured by GE Healthcare. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 6, 2010. Regulation: 8.