Device typeStereotactic neuronavigation/planning system: A mobile assembly of mains electricity (AC-powered) electronic and optical devices designed to receive and analyse patient magnetic resonance imaging (MRI) images and position landmarks manually or automatically on these images, then register the images by the mean of a three-dimensional (3-D) optical positioning system (frameless stereotactic neuronavigation) to provide real-time relative positioning for the treatment probes and instruments. It is typically used by healthcare providers in psychiatry, neuropsychiatry, and neurology for preoperative planning, in particular for consecutive image-guided transcranial magnetic stimulation (TMS) treatment sessions.
FDA categorySurgical planning software for neurological stereotaxic instruments
Device ID00873263009222
Catalog numberC0265-01
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information