
Ge Healthcare (Ge Medical Systems, LLC)
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SIGNA Premier is an FDA 510(k)-cleared medical device (K193282) manufactured by Ge Healthcare (Ge Medical Systems, LLC). This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 9, 2020. Regulation: 8.

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