← Back to catalogue
Veolity
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref Veo-2200Model 2.x510(k) K201501
Identity
- Trade Name
- Veolity EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- Veolity EUDAMED2.2.0, Release date 2024-12-20 FDA UDI
- Model / Reference
- 2.x EUDAMEDVeo-2200 EUDAMED2.2 FDA UDI
- Description
- 2.2.0, Release date 2024-12-20 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260483290244 EUDAMEDFDA UDI
- Basic UDI-DI
- 0426048329VEO35 EUDAMED
- Direct Marketing DI
- 04260483290244 EUDAMED
- 510(k) Number
- K201501 FDA UDI
- FDA Product Code
- OEB FDA UDILLZ FDA UDI
- EMDN Code
- Z11030682 COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Full-body CT system
Veolity by Mevis Medical Solutions Ag — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Full-body CT system.
- NAEOTOM Alpha.Prime — Siemens Healthcare · Class II
- SpotLight — Arineta , Ltd. · Class II
- TruPlan — Circle Cardiovascular Imaging Inc · Class IIa
- Osteo mat — Siemens Healthcare · Class II
- TOSHIBA SCANNER — Canon Medical Systems Corporation · Class II
- Bariatric table top — Siemens Healthcare · Class II
- Optima — Hangwei GE Medical Systems Co., Ltd. · Class II
- table extension_P68 — Siemens Shanghai Medical Equipment Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201501 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0426048329VEO35 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MeVis Medical Solutions AG
- EUDAMED SRN
- DE-MF-000005418
Sources (3)
- EUDAMED 27b999b7-e706-4560-b91d-e3a29f922cf4 85 fields · synced Jun 18, 2026
- FDA UDI 3f41b26b-e95c-4d57-9033-69cc0defab7b 34 fields · synced May 30, 2026
- FDA 510(k) K201501 1 fields · synced May 18, 2026