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Visia LungCAD
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref V-5800-LC510(k) K120207
Identity
- Trade Name
- Visia LungCAD FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- Visia LungCAD EUDAMED5.8.0.224889, Release date: 2017-12-13 5.8.1.246755, Release date: 2020-12-01 FDA UDI
- Model / Reference
- V-5800-LC EUDAMED5.8 FDA UDI
- Description
- 5.8.0.224889, Release date: 2017-12-13 5.8.1.246755, Release date: 2020-12-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260483290084 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04260483290084 EUDAMED
- 510(k) Number
- K043617 FDA UDI
- FDA Product Code
- OEB 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
- -1192 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Full-body CT system
Visia LungCAD by Mevis Medical Solutions Ag — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120207 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04260483290084 | Class IIa | Active |
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Manufacturer
- Manufacturer
- MeVis Medical Solutions AG
- EUDAMED SRN
- DE-MF-000005418
Sources (3)
- EUDAMED 6cb9474a-6873-49e4-8dff-17baa814f7db 85 fields · synced Jun 18, 2026
- FDA UDI 14dbb847-d383-4bd9-9dd2-300ad90063f2 34 fields · synced May 30, 2026
- FDA 510(k) K120207 1 fields · synced May 18, 2026