Data / Medical devices / Germany / Mevis Medical Solutions AG
Mevis Medical Solutions AG: FDA-registered device maker in Bremen, Germany, 5 510(k) clearances
Mevis Medical Solutions AG is registered with the FDA (registration 3010601176) in Bremen, Germany. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 30, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010601176
- Address
- Caroline-Herschel-Str. 1, Bremen, Germany, 28359
- Owner or operator
- Varex Imaging Corporation (10053550)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- May 30, 2017
- Registered through
- 2026
- Brand names listed
- DynaCAD Lung, DynaCAD Lung Server; Veolity LungCAD; Visia Lung, DynaCAD Lung; Veolity, MammoScape, MeVis AVM Contour, MeVis Liver Suite, Veolity, Veolity LungCAD and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lung Computed Tomography System, Computer-Aided Detection | OEB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 30, 2026 | K260576 | MeVis AVM Contour | LLZ | Substantially Equivalent | MeVis Medical Solutions AG | accessdata.fda.gov |
| October 27, 2023 | K232045 | MeVis Liver Suite | JAK | Substantially Equivalent | MeVis Medical Solutions AG | accessdata.fda.gov |
| February 23, 2021 | K201501 | Veolity | OEB | Substantially Equivalent | MeVis Medical Solutions AG | accessdata.fda.gov |
| December 21, 2007 | K043617 | IMAGECHECKER CT CAD SOFTWARE SYSTEM | OEB | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| November 20, 2002 | K023003 | IMAGECHECKER-CT WORKSTATION | LLZ | Substantially Equivalent | R2 Technology, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Lung Computed Tomography System, Computer-Aided Detection
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, Digital Image Communications, Radiological
Updated June 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.