
Nucletron Corp.
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PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1 is an FDA 510(k)-cleared medical device (K010784) manufactured by Nucletron Corp.. 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, 2001. Regulation: 8.