FDA.reportPublic FDA data

Stereotactic neuronavigation/planning system

Definition
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.
GUDID devices
88
Last updated
2026-06-11 06:06:20

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860012056828Zeta Navigation SystemZeta Surgical Inc.ZNS131-US2026-06-02
06430063200194Nexstim NBS White Head TrackerNexstim OyjNX1479492025-10-17
06430063200200Nexstim Head Tracker TapeNexstim OyjNX872462025-10-17
G076A012354A1Localite TMS Navigator TSLOCALITE GmbHAdhesive Pads, round (250 pcs.)2023-07-05
G076A012355A1Localite TMS Navigator TSLOCALITE GmbHAdhesive Pads, square-cut (90 Pcs.)2023-07-05
00860012056811Zeta TMS Navigation SystemZeta Surgical Inc.ZNS131-US2026-05-26
06430063200187Nexstim NBS SystemNexstim Oyj62025-04-01
00873263009222STarFix™ DesignerFHC, INC.C0265-01-009222024-07-12
00860011072515SAINTMagnus Medical, Inc.Magnus Neuromodulation Software2024-04-10
08908008085468Johari Digital Healthcare Ltd.SYRMA JOHARI MEDTECH LIMITEDZeta Cranial Navigation System2024-01-25
G076A001216B0Localite TMS Navigator TSLOCALITE GmbHCamera Cart for Vicra/Lyra2023-12-05
G076A010205AM3N40Localite TMS Navigator TSLOCALITE GmbHTMS Navigator SW MR-Based2023-12-05
G076A010206AM3N40Localite TMS Navigator TSLOCALITE GmbHTMS Navigator SW MR-Less2023-12-05
G076A010225AM3N40Localite TMS Navigator TSLOCALITE GmbHMR-Less (Image Data Component)2023-12-05
G076A010226AM3N40Localite TMS Navigator TSLOCALITE GmbHMR-Based (Image Data Component)2023-12-05
G076A010232AM3N40Localite TMS Navigator TSLOCALITE GmbHStimulation Response Export (Software Module)2023-12-05
G076A010233AM3N40Localite TMS Navigator TSLOCALITE GmbHFunctional Data (Software Module)2023-12-05
G076A010235AM3N40Localite TMS Navigator TSLOCALITE GmbHMagVenture Stimulator Control (Software Module)2023-12-05
G076A900649A0Localite TMS Navigator TSLOCALITE GmbHCamera Cart for Vega (LAN Cabling)2023-12-05
00873263009178STarFix™ DesignerFHC, INC.C0267-009172023-10-08
00873263008607STarFix™ DesignerFHC, INC.C0265-008602023-09-18
G076A001111A0Localite TMS Navigator TSLOCALITE GmbHPointer2023-07-05
G076A001164A0Localite TMS Navigator TSLOCALITE GmbHFoot switch, 3 Pedals2023-07-05
G076A001212A0Localite TMS Navigator TSLOCALITE GmbHCamera cart for Spectra/Vega2023-07-05
G076A001216A0Localite TMS Navigator TSLOCALITE GmbHCamera cart for Vicra2023-07-05
G076A002006A0Localite TMS Navigator TSLOCALITE GmbHCalibration Plate2023-07-05
G076A002009A0Localite TMS Navigator TSLOCALITE GmbHPointer ST2023-07-05
G076A002097A0Localite TMS Navigator TSLOCALITE GmbHCalibration Pins, 25/10 2023-07-05
G076A002209A0Localite TMS Navigator TSLOCALITE GmbHAdhesive Head Tracker2023-07-05
G076A003221A0Localite TMS Navigator TSLOCALITE GmbHTracker Top, Geo. 12023-07-05
G076A003222A0Localite TMS Navigator TSLOCALITE GmbHTracker Top, Geo. 22023-07-05
G076A010021A0Localite TMS Navigator TSLOCALITE GmbHAdapter Box2023-07-05
G076A010205AM3N30Localite TMS Navigator TSLOCALITE GmbHTMS Navigator SW MR-Based2023-07-05
G076A010206AM3N30Localite TMS Navigator TSLOCALITE GmbHTMS Navigator SW MR-Less2023-07-05
G076A010225AM3N30Localite TMS Navigator TSLOCALITE GmbHMR-Less (Image Data Component)2023-07-05
G076A010226AM3N30Localite TMS Navigator TSLOCALITE GmbHMR-Based (Image Data Component)2023-07-05
G076A010232AM3N30Localite TMS Navigator TSLOCALITE GmbHStimulation Response Export (Software Module)2023-07-05
G076A010233AM3N30Localite TMS Navigator TSLOCALITE GmbHFunctional Data (Software Module)2023-07-05
G076A010235AM3N30Localite TMS Navigator TSLOCALITE GmbHMagVenture Stimulator Control (Software Module)2023-07-05
G076A012354A0Localite TMS Navigator TSLOCALITE GmbHAdhesive Pads, round (250 pcs.)2023-07-05
G076A012355A0Localite TMS Navigator TSLOCALITE GmbHAdhesive Pads, square-cut (90 Pcs.)2023-07-05
G076A014221A0Localite TMS Navigator TSLOCALITE GmbHTracker Bracket, 25 mm2023-07-05
G076A014222A0Localite TMS Navigator TSLOCALITE GmbHTracker Bracket, 29 mm2023-07-05
G076A014226A0Localite TMS Navigator TSLOCALITE GmbHTracker Bracket, 38 mm2023-07-05
G076A014227A0Localite TMS Navigator TSLOCALITE GmbHAdhesive Base for Tracker 2023-07-05
G076A200001A0Localite TMS Navigator TSLOCALITE GmbHPivot-mounted Arm for Camera Cart/Wall Mount2023-07-05
G076A900587A0Localite TMS Navigator TSLOCALITE GmbHSystem Cart2023-07-05
B195NT1040tracking toolseemagine Medical Imaging Solutions GmbHNT-104.02022-09-21
B195NT1041tracking toolseemagine Medical Imaging Solutions GmbHNT-104.12022-09-21
B195NT106tracking toolseemagine Medical Imaging Solutions GmbHNT-1062022-09-21
B195NT109tracking toolseemagine Medical Imaging Solutions GmbHNT-1092022-09-21
B195NT112tracking toolseemagine Medical Imaging Solutions GmbHNT-1122022-09-21
B195NT117tracking toolseemagine Medical Imaging Solutions GmbHNT-1172022-09-21
B195NT118tracking toolseemagine Medical Imaging Solutions GmbHNT-1182022-09-21
B195NT120tracking toolseemagine Medical Imaging Solutions GmbHNT-1202022-09-21
B195NT123tracking toolseemagine Medical Imaging Solutions GmbHNT-1232022-09-21
B195NT124tracking toolseemagine Medical Imaging Solutions GmbHNT-1242022-09-21
B195NT125tracking toolseemagine Medical Imaging Solutions GmbHNT-1252022-09-21
B195NT126tracking toolseemagine Medical Imaging Solutions GmbHNT-1262022-09-21
B195NT133tracking toolseemagine Medical Imaging Solutions GmbHNT-1332022-09-21
B195NT134tracking toolseemagine Medical Imaging Solutions GmbHNT-1342022-09-21
B195NT143tracking toolseemagine Medical Imaging Solutions GmbHNT-1432022-09-21
B195NT148tracking toolseemagine Medical Imaging Solutions GmbHNT-1482022-09-21
B195NT157tracking toolseemagine Medical Imaging Solutions GmbHNT-1572022-09-21
B195NT158tracking toolseemagine Medical Imaging Solutions GmbHNT-1582022-09-21
B195NT159tracking toolseemagine Medical Imaging Solutions GmbHNT-1592022-09-21
B195NT105tracking toolseemagine Medical Imaging Solutions GmbHNT-1052022-09-20
B195ES600US0visor2eemagine Medical Imaging Solutions GmbHES-600.US2022-04-14
10889981189358Anterior Disc PrepSeaspine Orthopedics Corporation95-61952020-03-27
B195666601stimguideeemagine Medical Imaging Solutions GmbH6666012019-06-14
B195ES600stimguideeemagine Medical Imaging Solutions GmbHES-6002019-06-14
B195NH134stimguideeemagine Medical Imaging Solutions GmbHNH-1342019-06-14
B195NT103tracking toolseemagine Medical Imaging Solutions GmbHNT-1032019-06-14
B195NT115tracking toolseemagine Medical Imaging Solutions GmbHNT-1152019-06-14
B195NT149tracking toolseemagine Medical Imaging Solutions GmbHNT-1492019-06-14
B195NT150tracking toolseemagine Medical Imaging Solutions GmbHNT-1502019-06-14
B169CYGSAP102A0Compass InternationalCompass InternationalCYG-SAP-10-2A2016-08-12
06430063200026NexSpeech main softwareNexstim Oyj22016-09-21
06430063200033NexSpeech analyzer softwareNexstim Oyj22016-09-21
06430063200057Nexstim NBS SystemNexstim Oyj52016-09-21