Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MeVis Medical Solutions AG · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
263 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | 2026-06-30 | 130 | 0 |
| K232045 | MeVis Liver Suite | MeVis Medical Solutions AG | 2023-10-27 | 109 | 0 |
| K201501 | Veolity | MeVis Medical Solutions AG | 2021-02-23 | 263 | 0 |
| K120207 | VISIA | MeVis Medical Solutions AG | 2012-04-23 | 90 | 0 |
| K120484 | VISIA ONCOLOGY | MeVis Medical Solutions AG | 2012-03-27 | 39 | 0 |
| K113701 | VISIA NEURO | MeVis Medical Solutions AG | 2012-02-16 | 62 | 0 |
| K113337 | VISIA DYNAMIC REVIEW | MeVis Medical Solutions AG | 2011-12-30 | 46 | 0 |
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