CE-Kennzeichnung

In der EU sind Localite TMS Navigator Software und Zubehör CE-konforme Medizinprodukte. In den USA ist ausschließlich der Localite TMS Navigator TS von der FDA für folgende Zweckbestimmung freigegeben: The TMS Navigator TS helps users to plan, implement and document treatment involving TMS of the brain. The system provides planning and navigation functions using anatomical MR data. Regions of the brain to be stimulated can be determined on the basis of anatomy, functional areas or by entering previously calculated coordinates from brain atlases. The product is intended for use with the MagVenture therapy systems supplied by Tonica Elektronik A/S (Farum, Denmark), more precisely the R20 and R30 stimulators, the R30 TMS stimulator with MagOption, the X100 stimulator and the X100 stimulator with MagOption only with following magnetic coils: C-100, C-B60, Cool-B65, Cool-B70, Cool D-B80, MC-125, MC-B70, MCF-75, MCF-125, MCF-B65 and MMC-140-II. Andere Editionen (MR-compatible edition, robotic edition) dürfen außerhalb der EU nur zu Forschungszwecken eingesetzt werden. Classic Edition FDA-freigegebene Edition MR-Compatible Edition Robotic Edition Kooperationen Produkte TMS Navigator EEG PinPoint Forschung Vernetzter OP Assistenzsystem