MEVIS MEDICAL SOLUTIONS AG

FDA Device Registration & Listing · Bremen, DE · Registration 3010601176

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010601176
FEI Number
3010601176
Entity Name
MEVIS MEDICAL SOLUTIONS AG
City/State/Country
Bremen, DE
Establishment Address
Caroline-Herschel-Str. 1, Bremen 28359, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Varex Imaging Corporation (Owner Number: 10053550)
Owner / Operator Contact Address
1678 South Pioneer Road, Salt Lake City, UT 84104, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K232045
PMA Number
N/A

All Registered Proprietary Names

DynaCAD Lung Server; Veolity LungCAD; Visia Lung MeVis Liver Suite

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OEB Lung Computed Tomography System, Computer-Aided Detection Radiology Class 2 892.2050 2017-05-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2023-12-22

Official Correspondent

No official correspondent registered.

US Agent Details

Victor Garcia Business: Varex Imaging Corporation Email: victor.garcia@vareximaging.com Phone: (801) 9785399

Related Public Records

Same Entity

Varex Imaging Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3014205374 Varex Imaging Equipment (China) Co., LTD Wuxi Jiangsu, CN
1483291 Varex Imaging Corporation Franklin Park, IL, US
3006383214 Varex Imaging Nederland B.V. Doetinchem Gelderland, NL
3009519933 Varex Imaging Philippines Inc. Batino, Calamba City Laguna, PH
1717855 Varex Imaging Corporation SALT LAKE CITY, UT, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243523 Siemens Medical Solutions USA, Inc. NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime 2025-02-12
K781431 General Electric Co. ELECTRIC CT/T OPERATOR DISPLAY CONSOLE 1978-09-07
K231574 FUJIFILM Healthcare Americas Corporation Scenaria View 4.2 2023-10-12
K233583 FUJIFILM Healthcare Americas Corporation FCT iSTREAM Phase 1 2024-04-26
K151376 Covidien, LLC superDimension Navigation System 2015-11-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2011 GE Medical Systems, LLC 2
HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017 Philips Medical Systems 2
Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017 Philips Medical Systems 2
Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017 Philips Medical Systems 2
Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017 Philips Medical Systems 2
Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Similar Registrations

Registration Number Establishment Name Location
3017936680 Infervision Medical Technology Co., Ltd. Beijing, CN
3001722928 FUJIFILM CORPORATION ASHIGARAKAMI-GUN Kanagawa, JP
3004977335 Siemens Healthineers AG FORCHHEIM Bavaria, DE
9611343 GE MEDICAL SYSTEMS SCS BUC, FR
3015763655 Philips Medical Systems Technologies Ltd. Haifa, IL
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010601176. Last updated year: 2026. Please use registration number 3010601176 when referencing this establishment in official correspondence.
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