Eemagine Medical Imaging Solutions GmbH
Berlin, DE
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH appears in FDA device records in Berlin, DE. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Eemagine Medical Imaging Solutions GmbH between 2000 and 2024. The busiest year on record is 2000, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2011 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240575 | WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) | GXY | Substantially Equivalent | |
| K210109 | visor2 system | HAW | Substantially Equivalent | |
| K192889 | Neo | OMA | Substantially Equivalent | |
| K172312 | eego amplifiers | GWL | Substantially Equivalent | |
| K110223 | WAVEGUARD (TM) EEG CAP | GXY | Substantially Equivalent | |
| K070358 | MAXINSIGHT | OLX | Substantially Equivalent | |
| K051825 | COGNITRACE | GWQ | Substantially Equivalent | |
| K002631 | ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG | OLX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9612389 | 3003255845 | EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH | GUBENER STR. 47,, BERLIN D-10243 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GWLAmplifier, Physiological Signal
- OMAAmplitude-Integrated Electroencephalograph
- ORTBurst Suppression Detection Software For Electroencephalograph
- GXYElectrode, Cutaneous
- IKNElectromyograph, Diagnostic
- GWQFull-Montage Standard Electroencephalograph
- HAWNeurological Stereotaxic Instrument
- OMCReduced- Montage Standard Electroencephalograph
- OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph
- GWFStimulator, Electrical, Evoked Response
- OBPTranscranial Magnetic Stimulator
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain