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
124
Last updated
2026-08-03 17:33:52

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04719878691208Foot ControllerBRAIN NAVI BIOTECHNOLOGY CO., LTD.COFP10002026-07-25
04719878691246Display ScreenBRAIN NAVI BIOTECHNOLOGY CO., LTD.CODS00012026-07-25
04719878691307USB MouseBRAIN NAVI BIOTECHNOLOGY CO., LTD.COCO10032026-07-25
04719878691420Power Supply CordBRAIN NAVI BIOTECHNOLOGY CO., LTD.COWI02052026-07-25
04719878691468Power Supply Cord (US) 5mBRAIN NAVI BIOTECHNOLOGY CO., LTD.COWI02062026-07-25
04719878692021Surgical Equipment Drape PacksBRAIN NAVI BIOTECHNOLOGY CO., LTD.FPSD71012026-07-25
04719878693004Reference StylusBRAIN NAVI BIOTECHNOLOGY CO., LTD.FPRS01012026-07-25
04719878693042Tag SBRAIN NAVI BIOTECHNOLOGY CO., LTD.FPTA10002026-07-25
04719878693127Tag Support ArmBRAIN NAVI BIOTECHNOLOGY CO., LTD.COTA04822026-07-25
04719878694001Instrument Registration Platform CoverBRAIN NAVI BIOTECHNOLOGY CO., LTD.FPIR02112026-07-25
04719878695022Instrument Holder SBRAIN NAVI BIOTECHNOLOGY CO., LTD.FPIH00112026-07-25
04719878695046Instrument Adaptor (3 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.COIH03012026-07-25
04719878695060Instrument Adaptor (4 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.COIH03022026-07-25
04719878695084Instrument Adaptor (5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.COIH03032026-07-25
04719878695107Instrument Adaptor (8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.COIH03042026-07-25
04719878695121SEEG AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.FPIH03102026-07-25
04719878695145Catheter AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.FPIH04012026-07-25
04719878695169Thumb Screw of Instrument HolderBRAIN NAVI BIOTECHNOLOGY CO., LTD.COSC60112026-07-25
04719878695183Set Screw of Instrument HolderBRAIN NAVI BIOTECHNOLOGY CO., LTD.COSC30122026-07-25
04719878695206Pin Screw of Instrument AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.COSC30022026-07-25
04719878695220Catheter Adaptor_3.5mmBRAIN NAVI BIOTECHNOLOGY CO., LTD.FPIH04022026-07-25
04719878695244Instrument Adaptor (1.8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.COIH03002026-07-25
04719878695268Instrument Adaptor (2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.COIH03052026-07-25
04719878695282Instrument Adaptor (2.2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.COIH03062026-07-25
04719878695305Instrument Adaptor (2.5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.COIH03072026-07-25
04719878695329Instrument Adaptor (2.8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.COIH03082026-07-25
04719878695343Instrument Adator (3.2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.COIH03092026-07-25
04719878695367Instrument Adaptor (3.5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.COIH030A2026-07-25
04719878695381Instrument Adaptor (4.6 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.COIH030B2026-07-25
04719878695404Instrument Adaptor (5.2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.COIH030C2026-07-25
04719878695428Instrument Adaptor (6 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.COIH030D2026-07-25
04719878695442Instrument Adaptor (6.4 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.COIH030E2026-07-25
04719878695466Instrument Adaptor (7 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.COIH030F2026-07-25
04719878695480Basic Sterilization Case SetBRAIN NAVI BIOTECHNOLOGY CO., LTD.OPCA14912026-07-25
04719878696029Instrument Holder S SetBRAIN NAVI BIOTECHNOLOGY CO., LTD.FPIH11722026-07-25
G076A900588A0Localite TMS Navigator TSLOCALITE GmbHSystem Cart2026-06-22
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