Ziehm Vision FD
Ziehm Imaging GmbHZiehm Vision FD is a mobile fluoroscopic X-ray system designed to provide continuous and pulsed fluoroscopic imaging during diagnostic, interventional, and surgical procedures. It helps clinicians visualize complex anatomical structures such as vascular, cardiac, and neurologic areas in real-time to better localize and treat pathological regions, improving accuracy in surgical and critical care settings. The system offers high-resolution flat panel displays, motorized and manual movement axes for precise positioning, and supports multiple peripheral interfaces, enhancing surgical workflow and patient care.
Intended Use
The Ziehm Vision FD is intended for use in providing medical imaging for general populations. The device provides pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, emergency room procedures, and where higher accuracy in Image geometry is required. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.
Technology
The Ziehm Vision FD mobile fluoroscopy system consists of a mobile stand with a C-Profile shaped support integrating a mono-block high voltage generator assembly and a flat panel image receptor. It performs 2D medical imaging with four axes of manual movement and one vertical motorized axis. It includes a touch screen for selectable anatomical programs and X-ray control, high-resolution flat panel display monitors for live image visualization, cable bound and optional wireless fluoroscopic footswitches, and interfaces for external devices including DICOM network connections. The device incorporates IGZO flat panel detectors with manufacturing technology Indium-Gallium-Zinc-Oxide, providing high image quality.
Performance
Performance testing included bench testing of physical characteristics, operational functions, exposure features, and safety in compliance with FDA and relevant safety standards. Image quality was evaluated using anthropomorphic and motion phantoms demonstrating better or equal image quality compared to predicate devices, including pediatric dose testing. Software and cybersecurity testing were performed, including vulnerability scanning and penetration testing, confirming good cybersecurity posture. The overall testing demonstrated that the device meets requirements for safety, effectiveness, and fulfills intended use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/4/2024
3 months - 2
FDA Approval
3/13/2025
Other devices from Ziehm Imaging GmbH
- Ziehm Solo FD2025 • 510K
- Ziehm Vision RFD 3D2025 • 510K
- Ziehm Vision RFD2025 • 510K
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