FDA.reportPublic FDA data

Localite TMS Navigator TS

Primary DI
G076A010233AM3N40
Brand
Localite TMS Navigator TS
Company
LOCALITE GmbH
Model
Functional Data (Software Module)
Catalog number
10233
Published
2023-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223577000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223577000Localite TMS Navigator TSLocalite GmbH2023-04-17HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G076A010233AM3N30PreviousHIBCC0
G076A010233AM3N40PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic neuronavigation/planning systemA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315271657
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G076A900687A0Localite TMS Navigator TSAdapterbox9006872026-08-03
G076A900588A0Localite TMS Navigator TSSystem Cart9005882026-06-22
G076A001216B0Localite TMS Navigator TSCamera Cart for Vicra/Lyra2023-12-05
G076A010205AM3N40Localite TMS Navigator TSTMS Navigator SW MR-Based102052023-12-05
G076A010206AM3N40Localite TMS Navigator TSTMS Navigator SW MR-Less102062023-12-05
G076A010225AM3N40Localite TMS Navigator TSMR-Less (Image Data Component)102252023-12-05
G076A010226AM3N40Localite TMS Navigator TSMR-Based (Image Data Component)102262023-12-05
G076A010232AM3N40Localite TMS Navigator TSStimulation Response Export (Software Module)102322023-12-05
G076A010235AM3N40Localite TMS Navigator TSMagVenture Stimulator Control (Software Module)102352023-12-05
G076A900649A0Localite TMS Navigator TSCamera Cart for Vega (LAN Cabling)9006492023-12-05
G076A001216A0Localite TMS Navigator TSCamera cart for Vicra0012162023-07-05
G076A010205AM3N30Localite TMS Navigator TSTMS Navigator SW MR-Based102052023-07-05
G076A010206AM3N30Localite TMS Navigator TSTMS Navigator SW MR-Less102062023-07-05
G076A010225AM3N30Localite TMS Navigator TSMR-Less (Image Data Component)102252023-07-05
G076A010226AM3N30Localite TMS Navigator TSMR-Based (Image Data Component)102262023-07-05
G076A010232AM3N30Localite TMS Navigator TSStimulation Response Export (Software Module)102322023-07-05
G076A010233AM3N30Localite TMS Navigator TSFunctional Data (Software Module)102332023-07-05
G076A010235AM3N30Localite TMS Navigator TSMagVenture Stimulator Control (Software Module)102352023-07-05
G076A012354A1Localite TMS Navigator TSAdhesive Pads, round (250 pcs.)123542023-07-05
G076A012355A1Localite TMS Navigator TSAdhesive Pads, square-cut (90 Pcs.)123552023-07-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07340201503683Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
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07340201503720Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503744Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503768Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503942Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
07340201503959Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2026-08-18
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00763000989958Stealth AXiS™ GEHC Craniotomy Transducer TrackerMEDTRONIC NAVIGATION, INC.HAW2026-08-15
00763000989965Stealth AXiS™ GEHC craniotomy Transducer Verification DeviceMEDTRONIC NAVIGATION, INC.HAW2026-08-15
00199150054466N/AMEDTRONIC NAVIGATION, INC.HAW2026-08-08
00763000381141N/AMEDTRONIC NAVIGATION, INC.HAW2026-08-08
00199150054398StealthStation S8MEDTRONIC NAVIGATION, INC.HAW2026-08-07
G076A900687A0Localite TMS Navigator TSLOCALITE GmbHHAW2026-08-03
04719878691024Nao Trac SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691208Foot ControllerBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691246Display ScreenBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691307USB MouseBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691420Power Supply CordBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691468Power Supply Cord (US) 5mBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878692021Surgical Equipment Drape PacksBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693004Reference StylusBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693042Tag SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693127Tag Support ArmBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878694001Instrument Registration Platform CoverBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695022Instrument Holder SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695046Instrument Adaptor (3 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695060Instrument Adaptor (4 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695084Instrument Adaptor (5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25