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Eemagine Medical Imaging Solutions GMBH: FDA-registered device maker in Berlin, Germany, 7 510(k) clearances

Name: Eemagine Medical Imaging Solutions GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Eemagine Medical Imaging Solutions GMBH is registered with the FDA (registration 9612389) in Berlin, Germany. It lists 10 device types. The FDA files 7 510(k) clearances under its listings, the newest dated November 25, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9612389
FEI number: 3003255845
Address: Gubener STR. 47, Fabrikgebaeude, Berlin, Germany, D-10243
Owner or operator: EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH (9042702)
Roles: Manufacturer
First device listed: September 8, 2011
Registered through: 2026
Brand names listed: StimGuide, WaveGuard, cognitrace, eego, eego amplifier, neo, neo monitor, visor2 system and more

Devices it lists

Device	Product code	Class	Role	Source
Amplifier, Physiological Signal	GWL	2	Manufacturer	accessdata.fda.gov
Amplitude-Integrated Electroencephalograph	OMA	2	Manufacturer	accessdata.fda.gov
Burst Suppression Detection Software For Electroencephalograph	ORT	2	Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Electromyograph, Diagnostic	IKN	2	Manufacturer	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Manufacturer	accessdata.fda.gov
Reduced- Montage Standard Electroencephalograph	OMC	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Evoked Response	GWF	2	Manufacturer	accessdata.fda.gov
Transcranial Magnetic Stimulator	OBP	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 25, 2024	K240575	WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)	GXY	Substantially Equivalent	Eemagine Medical Imaging Solutions GmbH	accessdata.fda.gov
April 8, 2022	K210109	visor2 system	HAW	Substantially Equivalent	Eemagine Medical Imaging Solutions GmbH	accessdata.fda.gov
January 30, 2020	K192889	Neo	OMA	Substantially Equivalent	Eemagine Medical Imaging Solutions GmbH	accessdata.fda.gov
April 3, 2019	K183376	HORIZON TMS Therapy System with Navigation	OBP	Substantially Equivalent	Magstim Company, Ltd.	accessdata.fda.gov
March 30, 2018	K172312	eego amplifiers	GWL	Substantially Equivalent	Eemagine Medical Imaging Solutions GmbH	accessdata.fda.gov
June 29, 2011	K110223	WAVEGUARD (TM) EEG CAP	GXY	Substantially Equivalent	Eemagine Medical Imaging Solutions GmbH	accessdata.fda.gov
September 12, 2005	K051825	COGNITRACE	GWQ	Substantially Equivalent	Eemagine Medical Imaging Solutions GmbH	accessdata.fda.gov

Compare with other makers

Updated November 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.