FDA Registration
Active
🇩🇪 Germany
MEVIS MEDICAL SOLUTIONS AG
Reg #: 3010601176
·
FEI: 3010601176
·
Expires 2026
Products
4
Proprietary Names
8
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- MEVIS MEDICAL SOLUTIONS AG
- Registration Number
- 3010601176
- FEI Number
- 3010601176
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Caroline-Herschel-Str. 1
- City
- Bremen
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K043617
Owner / Operator
- Firm Name
- Varex Imaging Corporation
- Operator Number
- 10053550
- Address
- 1678 South Pioneer Road
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84104
- Country
- US
US Agent
- Business Name
- Varex Imaging Corporation
- Contact Name
- Victor Garcia
- Address
- 1678 South Pioneer Road
- City
- Salt Lake City
- State
- UT
- ZIP
- 84104
- Country
- US
- [email protected]
- Phone
- 801 9785399
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lung Computed Tomography System, Computer-Aided Detection | OEB | Class 2 | Radiology | No | 2017-05-30 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2023-12-22 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2024-09-25 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2017-05-30 |
Proprietary Names
DynaCAD Lung Server; Veolity LungCAD; Visia Lung
MeVis Liver Suite
MammoScape
DynaCAD Lung; Veolity
Veolity
DynaCAD Lung
Veolity LungRead
Veolity LungCAD
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device