Eemagine Medical Imaging Solutions GmbH: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Eemagine Medical Imaging Solutions GmbH” (first 2000, latest 2024), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 164 days. Since 2017 the median was 255 days, against 144 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 241 |
| 2019 | 0 | — |
| 2020 | 1 | 112 |
| 2021 | 0 | — |
| 2022 | 1 | 444 |
| 2023 | 0 | — |
| 2024 | 1 | 269 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Eemagine Medical Imaging Solutions GmbH took a median 255 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 144 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXY | Electrode, Cutaneous | 2 | 2 |
| OLX | Source Localization Software For Electroencephalograph Or Magnetoencephalograph | 2 | 2 |
| GWL | Amplifier, Physiological Signal | 1 | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 | 1 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
| OMA | Amplitude-Integrated Electroencephalograph | 1 | 1 |
Review panels
- Neurology (8)
Most recent Eemagine Medical Imaging Solutions GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240575 | WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) | GXY | 2024-11-25 | 269 |
| K210109 | visor2 system | HAW | 2022-04-08 | 444 |
| K192889 | Neo | OMA | 2020-01-30 | 112 |
| K172312 | eego amplifiers | GWL | 2018-03-30 | 241 |
| K110223 | WAVEGUARD (TM) EEG CAP | GXY | 2011-06-29 | 155 |
| K070358 | MAXINSIGHT | OLX | 2007-07-30 | 173 |
| K051825 | COGNITRACE | GWQ | 2005-09-12 | 69 |
| K002631 | ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG | OLX | 2000-10-23 | 61 |
Recalls
openFDA lists no recalls under a recalling firm named Eemagine Medical Imaging Solutions GmbH.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Eemagine Medical Imaging Solutions GmbH?
FDA lists 8 510(k) clearances under the applicant name “Eemagine Medical Imaging Solutions GmbH” (first 2000, latest 2024), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Eemagine Medical Imaging Solutions GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eemagine Medical Imaging Solutions GmbH is 164 days. Since 2017: 255 days, versus 144 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Eemagine Medical Imaging Solutions GmbH?
The most frequent FDA product codes under this applicant name are GXY (Electrode, Cutaneous, 2); OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph, 2); GWL (Amplifier, Physiological Signal, 1).
Next steps
- See all 8 Eemagine Medical Imaging Solutions GmbH clearances with predicates and recalls
- Run predicate analysis for product code GXY, Eemagine Medical Imaging Solutions GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.