Vivix-S 2530VW
by Vieworks Co., Ltd. EUDAMEDGUDID
Active
Ref FXRD-2530VAW PLUSModel VIVIX-S VW Series, VIVIX-S FW Series, VIVIX-S VR Series
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number880939433VIVIXSVW2H | Date30 Jan 2024 | StatusActive |
| United States | GUDID listing GUDID | Number08809394330302 | Date6 Oct 2020 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- Vivix-S 2530VW EUDAMEDVivix-S 2530VAW Plus GUDID
- Generic Name
- Indirect flat panel x-ray detector
- Device Name
- Digital Imaging System
- Model / Reference
- VIVIX-S VW Series, VIVIX-S FW Series, VIVIX-S VR Series, FXRD-2530VAW PLUS
- Description
- Flat Panel Detector, wireless 25cm by 30 cm of size
- Primary DI / UDI-DI
- 08809394330302
- 510(k) Number
- FDA Product Code
- MQB
- GMDN Term
- Indirect flat panel x-ray detector
- Regulation Number
- 892.1680
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- KR-MF-000020017
- Authorised representative
- Vieworks EU GmbH DE-AR-000052174