
GE Medical Systems
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MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM is an FDA 510(k)-cleared medical device (K003575) manufactured by GE Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 16, 2001. Regulation: 8.