
Siemens Medical Solutions USA, Inc.
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RADIOTOM 804 is an FDA 510(k)-cleared medical device (K844428) manufactured by Siemens Medical Solutions USA, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 19, 1985. Regulation: 8.