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
Phone
801 9785399

Products

Device Name Product Code
Lung Computed Tomography System, Computer-Aided Detection OEB
System, X-Ray, Tomography, Computed JAK
System, Digital Image Communications, Radiological LMD
System, Image Processing, Radiological LLZ

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