Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Eemagine Medical Imaging Solutions GmbH · Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

173 daysmedian FDA review time
444 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K240575WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-27Eemagine Medical Imaging Solutions GmbH2024-11-252690
K210109visor2 systemEemagine Medical Imaging Solutions GmbH2022-04-084440
K192889NeoEemagine Medical Imaging Solutions GmbH2020-01-301120
K172312eego amplifiersEemagine Medical Imaging Solutions GmbH2018-03-302410
K110223WAVEGUARD (TM) EEG CAPEemagine Medical Imaging Solutions GmbH2011-06-291550
K070358MAXINSIGHTEemagine Medical Imaging Solutions GmbH2007-07-301730
K051825COGNITRACEEemagine Medical Imaging Solutions GmbH2005-09-12690
K002631ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEGEemagine Medical Imaging Solutions GmbH2000-10-23610

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda