Identity
- Trade Name
- Vision U EUDAMEDVISION FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Visaris Vision combines our Visaris Avanse® cleared PACS software (K150725) with all the other components required to make a complete digital diagnostic X‐ray system, including tube stands, tube heads, collimators, generators, tables, and (already cleared) digital X‐ray panels. FDA UDI
- Model / Reference
- Vision U EUDAMEDFDA UDI1830005 EUDAMED
- Description
- Visaris Vision combines our Visaris Avanse® cleared PACS software (K150725) with all the other components required to make a complete digital diagnostic X‐ray system, including tube stands, tube heads, collimators, generators, tables, and (already cleared) digital X‐ray panels. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08606102809118 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08606102809118 EUDAMED
- 510(k) Number
- K160620 FDA UDI
- FDA Product Code
- KPR FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Stationary basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stationary basic diagnostic x-ray system, digital
Vision U by Visaris — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08606102809118 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Visaris
- EUDAMED SRN
- RS-MF-000005209
- Authorised Representative
- VISARIS d.o.o. SI-AR-000022682
Sources (2)
- EUDAMED 3d858d17-f7f7-4a4a-af8c-1653bbb393f2 61 fields · synced Aug 3, 2026
- FDA UDI 3285ea86-f300-4fc8-9819-e31a76860e76 36 fields · synced May 30, 2026