
Nuclemed S.A.
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WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM is an FDA 510(k)-cleared medical device (K090190) manufactured by Nuclemed S.A.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 8, 2009. Regulation: 8.