Visaris Vision® (Vision C, Vision U. Vision V, Vision X)
by Visaris D.O.O. Belgrade EUDAMED510(k)
Active
510(k) K160620
Overview
The Visaris Vision series comprises modular digital radiography (DR) systems, classified as stationary X-ray systems. These devices generate high-quality radiographic images for diagnostic purposes across various medical specialties, including musculoskeletal, trauma, and general radiology. Each model—Vision C, Vision U, Vision V, and Vision X—is engineered to deliver precise imaging with customizable configurations to suit different clinical workflows and room constraints.
The Vision series is supplied as reusable medical equipment, designed for use in radiology departments and imaging suites. Models like Vision C feature highly mobile overhead tube stands paired with fixed or portable detectors, while Vision V integrates floor-mounted tube stands with vertical Bucky stands and tables. All systems are intended for stationary use and comply with regulatory standards, including FDA 510(k) clearance and MDD authorization. No sterility or single-use specifications are noted; maintenance and calibration follow manufacturer guidelines for optimal performance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK160620 | Date30 Mar 2016 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
-
- Terminated Z-1880-2018
- Terminated Z-1882-2018
- Terminated Z-1881-2018
A failure of the tube arm suspension is possible while the tube arm height is being adjusted. During tube height adjustment there is a small probability of failure of both the primary and redundant holding mechanisms, causing uncontrollable descent of the tube arm and a potential risk of injury to the patient.
Specification
- 510(k) Number
- FDA Product Code
- KPR
- Regulation
- 21 CFR Part 892.1680
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Visaris D.O.O. Belgrade
Questions
What are the key differences between the Vision C and Vision V models in terms of setup and mobility?
The Vision C model is designed for high mobility, featuring overhead tube stands that can be easily repositioned, paired with either fixed or portable detectors. In contrast, the Vision V model is configured for stationary use with floor-mounted tube stands and includes vertical Bucky stands and tables, making it more suited for fixed radiology rooms where flexibility in movement isn’t required. This distinction caters to different clinical workflows—Vision C for dynamic environments, while Vision V prioritizes stability and integration into permanent setups.
Are these systems intended for single-use or reusable applications, and what maintenance is required?
The Visaris Vision series is explicitly designed as reusable medical equipment, not for single-use. Like all reusable X-ray systems, it requires regular maintenance, calibration, and servicing as outlined by the manufacturer to ensure optimal performance, safety, and compliance with regulatory standards. No sterility specifications are noted, as these systems are not sterilized between uses.
How do I determine which model is best suited for my radiology department’s needs?
The choice depends on your department’s workflow and space constraints. The Vision C is ideal for environments needing flexibility, such as trauma or mobile imaging, due to its overhead tube stands and portable detector options. The Vision U, Vision V, and Vision X models offer more stationary configurations, with Vision V including floor-mounted stands and Bucky tables, making it better suited for high-volume or specialized radiology suites. Assess your imaging volume, room layout, and mobility requirements to select the appropriate model.
What regulatory pathways have these systems undergone, and how does that affect their use?
The Visaris Vision series has undergone FDA 510(k) clearance and MDD authorization, confirming compliance with U.S. and European regulatory standards for stationary X-ray systems. This means the devices meet established safety and performance criteria for diagnostic radiography in musculoskeletal, trauma, and general radiology. The regulatory route ensures the systems are suitable for clinical use in radiology departments, though actual deployment depends on local facility protocols and accreditation requirements.