FDA.reportPublic FDA data

stimguide

Primary DI
B195ES600
Brand
stimguide
Company
eemagine Medical Imaging Solutions GmbH
Model
ES-600
Device description
StimGuide component
Published
2019-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K183376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183376000HORIZON TMS Therapy System with NavigationMagstim Company, Ltd.2019-04-03OBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B195ES600PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+493029048404support@eemagine.com

Regulatory Flags#

DUNS number
313152485
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B195XC813waveguardXC-8132026-03-19
B195CA520waveguardCA-5202025-12-16
B195CA521waveguardCA-5212025-12-16
B195CA522waveguardCA-5222025-12-16
B195NA215waveguardNA-2152025-12-16
B195NA276waveguardNA-2762025-12-16
B195NA415waveguardNA-4152025-12-16
B195XC315waveguardXC-3152025-12-16
B195XS268waveguardXS-2682025-12-16
B195XS269waveguardXS-2692025-12-16
B195XS272waveguardXS-2722025-12-16
B195XS297waveguardXS-2972025-12-16
B195EE223eego amplifierEE-2232025-09-29
B195EE225eego amplifierEE-2252025-09-29
B195LC100cognitraceLC-1002021-07-27
B195LC104cognitraceLC-1042020-04-30
B195LC105cognitraceLC-1052020-04-30
B195LC106cognitraceLC-1062020-04-30
B195LC107cognitraceLC-1072020-04-30
B195SC100cognitraceSC-1002020-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000811129MedtronicMEDTRONIC NAVIGATION, INC.HAW2026-06-07
00860012056828Zeta Navigation SystemZeta Surgical Inc.HAW2026-06-02
08720892330826Ball Joint Guide Array (BJGA)-Navigation SetBayer Medical Care B.V.HAW2026-04-24
08720892330833Ball Joint Guide Array (BJGA)-Guide SetBayer Medical Care B.V.HAW2026-04-24
07340201501887Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2025-03-31
10381780542278CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-28
10381780542285CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-28
10381780542292Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-03
G076A012354A1Localite TMS Navigator TSLOCALITE GmbHHAW2023-07-05
G076A012355A1Localite TMS Navigator TSLOCALITE GmbHHAW2023-07-05
07613327499711N/AStryker Leibinger GmbH & Co. KGHAW2023-03-23
07613327500516N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327500561N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327500578N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327503265N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
10603295522850VELYSDEPUY (IRELAND)HAW2021-07-30
07613327413076n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
07613327413090n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
07613327413205n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
10603295493624SIGMADEPUY ORTHOPAEDICS, INC.HAW2018-04-19
10650551098277PMT CORPORATION - STEREOTACTICPMT CORPORATIONHAW2018-01-28
10381780167334CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252252CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252351Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252368Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252375CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252382Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252399Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252405CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252412CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14