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510(k) Data Aggregation
K Number
K223577Device Name
Localite TMS Navigator TS
Manufacturer
Date Cleared
2023-04-17
(138 days)
Product Code
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Localite GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TMS Navigator TS helps users to plan, implement 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 stimulator with MagOption, the X100 stimulator and the X100 stimulator with MagOption only with following magnetic coils: C-100, C-B60, Cool-B70, Cool D-B80, MC-125, MC-B70, MCF-75, MCF-125, MCF-B65 and MMC-140-II.
Device Description
The TMS Navigator TS is a navigation system specifically designed to support transcranial magnetic stimulation (TMS).
It uses position data of the patient's head and the TMS coil acquired by an optical tracking system for display and navigation. The realtime display of the position of the TMS coil in the displayed MR data set provides visual support for navigation. With the help of the software, one or more locations for the TMS treatment can be planned as well as stimulated locations can be recorded in the used data set and thus documented.
These functionalities support the following use case:
Planning, execution and documentation of a TMS stimulation in the human brain.
Transcranial magnetic stimulation (TMS) uses so-called TMS coils to generate alternating electromagnetic fields to target brain areas. The depth of penetration, extent and nature of this effect (inhibitory or exhibitory) is influenced by the strength and shape of the magnetic field and the repetition frequency used.
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