Localite TMS Navigator TS
Localite TMS Navigator TS provides MRI-based planning and navigation for transcranial magnetic stimulation. It helps identify a brain region and position a compatible treatment coil over…
Localite TMS Navigator TS provides MRI-based planning and navigation for transcranial magnetic stimulation. It helps identify a brain region and position a compatible treatment coil over the selected target.
Targets can be defined from anatomical structures, functional regions or previously calculated atlas coordinates. During treatment, the navigation system supports placement at that planned location.
Navigation Accessory
The system works with specified MagVenture stimulators and coil models. It provides planning, implementation and treatment-documentation functions as an accessory; it does not itself include the magnetic stimulator that supplies the treatment pulses.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Sinovation (Beijing) Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
Record
| Listed by | Localite Gmbh, Germany |
|---|---|
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Manufacturer |
| 510(k) | K223577 |
| Record published | 2023-07-05 |
| Record revised | 2026-06-23 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2026-06-22 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Pointer ST | In distribution | ||
| Stimulation Response Export (Software Module) | In distribution | ||
| Foot switch, 3 Pedals | In distribution | ||
| Camera Cart for Vicra/Lyra | In distribution | ||
| TMS Navigator SW MR-Based | In distribution | ||
| System Cart | In distribution | ||
| TMS Navigator SW MR-Less | In distribution | ||
| Adapter Box | In distribution | ||
| Tracker Bracket, 29 mm | In distribution | ||
| Calibration Plate | In distribution | ||
| Pivot-mounted Arm for Camera Cart/Wall Mount | In distribution | ||
| Adhesive Base for Tracker | In distribution | ||
| Tracker Top, Geo. 1 | In distribution | ||
| Pointer | In distribution | ||
| Camera cart for Spectra/Vega | In distribution | ||
| MagVenture Stimulator Control (Software Module) | In distribution | ||
| Adhesive Pads, round (250 pcs.) | 250 | In distribution | |
| Calibration Pins, 25/10 | In distribution | ||
| MR-Less (Image Data Component) | In distribution | ||
| Tracker Top, Geo. 2 | In distribution | ||
| Functional Data (Software Module) | In distribution | ||
| Tracker Bracket, 25 mm | In distribution | ||
| MR-Based (Image Data Component) | In distribution | ||
| Tracker Bracket, 38 mm | In distribution | ||
| Adhesive Head Tracker | In distribution | ||
| Camera Cart for Vega (LAN Cabling) | In distribution | ||
| Adhesive Pads, square-cut (90 Pcs.) | 90 | In distribution | |
| System Cart | Withdrawn | ||
| TMS Navigator SW MR-Based | Withdrawn | ||
| MR-Less (Image Data Component) | Withdrawn | ||
| Camera cart for Vicra | Withdrawn | ||
| Stimulation Response Export (Software Module) | Withdrawn | ||
| TMS Navigator SW MR-Less | Withdrawn | ||
| MR-Based (Image Data Component) | Withdrawn | ||
| MagVenture Stimulator Control (Software Module) | Withdrawn | ||
| Functional Data (Software Module) | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neurological Stereotaxic Instrument | Medtronic Navigation, Inc. | 844 |
| PMT Corporation – Stereotactic | PMT Corp. | 255 |
| Leksell Stereotactic System | Elekta Instrument AB | 199 |
| Neurological Stereotaxic Instrument | Inomed Medizintechnik Gmbh | 146 |
| Neurological Stereotaxic Instrument | Stryker Leibinger Gmbh & Co. KG | 125 |
| Geniant Cranial | KOH Young Technology Inc. | 113 |
| CRW® | Integra Lifesciences Corporation | 107 |
| Leksell Stereotactic System | Elekta Solutions AB | 93 |
| microTargeting™ Insertion Tube with Stylet | FHC, Inc. | 60 |
| Leksell Stereotactic System Neurosurgical Instruments | Elekta Instrument AB | 58 |
| Leksell Vantage Stereotactic System | Elekta Instrument AB | 53 |
| Stealth Autoguide™ System | Medtronic Navigation, Inc. | 50 |
Showing 12 of 1,137. All products under Neurological Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223577 | 2023-04-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.