MeVis Medical Solutions AG: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “MeVis Medical Solutions AG” (first 2011, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 130 days, against 122 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 | 3 | 62 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 263 |
| 2022 | 0 | — |
| 2023 | 1 | 109 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 130 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name MeVis Medical Solutions AG took a median 130 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 4 | 4 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
| OEB | Lung Computed Tomography System, Computer-Aided Detection | 1 | 1 |
Review panels
- Radiology (7)
Most recent MeVis Medical Solutions AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260576 | MeVis AVM Contour | LLZ | 2026-06-30 | 130 |
| K232045 | MeVis Liver Suite | JAK | 2023-10-27 | 109 |
| K201501 | Veolity | OEB | 2021-02-23 | 263 |
| K120207 | VISIA | LLZ | 2012-04-23 | 90 |
| K120484 | VISIA ONCOLOGY | LLZ | 2012-03-27 | 39 |
| K113701 | VISIA NEURO | LLZ | 2012-02-16 | 62 |
| K113337 | VISIA DYNAMIC REVIEW | LNH | 2011-12-30 | 46 |
Recalls
openFDA lists no recalls under a recalling firm named MeVis Medical Solutions AG.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under MeVis Medical Solutions AG (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Mevis Technology GmbH & Co. KG (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under MeVis Medical Solutions AG?
FDA lists 7 510(k) clearances under the applicant name “MeVis Medical Solutions AG” (first 2011, latest 2026), across 4 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 MeVis Medical Solutions AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name MeVis Medical Solutions AG is 90 days. Since 2017: 130 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under MeVis Medical Solutions AG?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 4); JAK (System, X-Ray, Tomography, Computed, 1); LNH (System, Nuclear Magnetic Resonance Imaging, 1).
Next steps
- See all 7 MeVis Medical Solutions AG clearances with predicates and recalls
- Run predicate analysis for product code LLZ, MeVis Medical Solutions AG'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.