3D Neuronavigation - India CDSCO Medical Device Registration
3D Neuronavigation is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001305_923d115008d147b0f28cbbed1867a7d8_67618bdb5694a8e08abf2099b7342c26. This device is marketed under the brand name visor2. The license holder is Hospimedica International Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
visor2
License Holder
Hospimedica International Ltd.Device Class
Approving Authority
CDSCO
Product Information
visor2 is used to aid 3D navigation for positioning of Transcranial Magnetic Stimulation (visor2) coils with the help of Robotic Arm over preselected brain regions in scientific research or clinical procedures. visor2 is to be used with a compatible TMS stimulator, a compatible optical tracking system and further compatible accessories. Optionally, a compatible amplifier for measuring electrophysiological signals can be connected. visor2 allows to record and view electrophysiological signals from the patient. It visualizes the activated motor cortex area over the anatomical images of the patient's brain based on the analysis of the evoked muscle response after the application of a TMS pulse. The visor2 system must be operated by a trained physician and must not be used during surgical operations
