Vivix-S with VXVue
by Vieworks Co., Ltd. South Korea EUDAMED510(k)
510(k) K122866 Product code MQB
Overview
The Vivix-S with VXVue is a Solid State X-Ray Imager (Flat Panel/Digital Imager), designed to capture and display radiographic images in real-time. It converts X-ray exposure into digital signals for immediate visualisation, enabling high-resolution imaging for diagnostic radiology procedures. This device is classified as a Class II medical device under FDA regulations, requiring substantial equivalence to predicate technologies for clearance.
This system is intended for use in radiology departments, hospitals, and clinical settings where digital X-ray imaging is required. Supplied as a reusable device, it must undergo appropriate sterilisation or disinfection protocols between uses. The Vivix-S with VXVue operates within standard MRI safety guidelines for non-MRI environments and is available in multiple model variants as referenced by the listed FEI numbers. Authorisations include FDA 510(k) clearance, MDD, and MDR compliance, ensuring adherence to regulatory standards for digital radiographic imagers.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK122866 | Date11 Jan 2013 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- MQB
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vieworks Co., Ltd.
Questions
What types of clinical environments is the Vivix-S with VXVue intended for, and how does its real-time imaging capability benefit radiology workflows?
The Vivix-S with VXVue is designed for radiology departments, hospitals, and clinical settings where digital X-ray imaging is required. Its real-time imaging capability allows immediate visualization of radiographic images, which enhances workflow efficiency by reducing delays between capture and review. This is particularly useful for procedures requiring precise, on-the-fly adjustments, such as fluoroscopy or interventional radiology.
Is the Vivix-S with VXVue a single-use or reusable device, and what sterilization or disinfection protocols should be followed between uses?
The Vivix-S with VXVue is a reusable device, meaning it must undergo appropriate sterilization or disinfection protocols between uses to ensure safety and maintain performance. Since it is classified as a reusable medical device, adherence to validated protocols—such as those using ethylene oxide, steam sterilization, or high-level disinfection—is critical to prevent cross-contamination and preserve functionality.
How many model variants of the Vivix-S with VXVue are available, and how can I identify the correct variant for my needs?
The Vivix-S with VXVue is available in multiple model variants, each identified by a unique FEI (Facility Equipment Identifier) number. Over 80 distinct FEI numbers are listed, indicating a range of configurations or specifications. To determine the correct variant, consult the manufacturer’s documentation or contact Vieworks Co., Ltd. for guidance tailored to your specific clinical or operational requirements.
Does the Vivix-S with VXVue comply with MRI safety guidelines, and where should it be used?
The Vivix-S with VXVue operates within standard MRI safety guidelines for non-MRI environments. This means it is not designed for use inside MRI suites or areas with strong magnetic fields. It should only be deployed in radiology departments or clinical settings where MRI compatibility is not a concern, ensuring safe and reliable operation.
What regulatory pathways has the Vivix-S with VXVue undergone, and how does this affect its adoption in different markets?
The Vivix-S with VXVue has undergone FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) compliance, confirming its adherence to regulatory standards in the U.S., EU, and other jurisdictions following MDR. This multi-market authorization streamlines adoption by ensuring the device meets stringent safety and performance criteria across these regions, though local compliance may still require additional steps.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K122866
- EUDAMED