Ziehm Vision RFD
Ziehm Imaging GmbHThe Ziehm Vision RFD is a mobile fluoroscopy system with a flat panel detector used to provide real-time digital imaging during diagnostic and interventional surgical procedures. It helps clinicians visualize complex anatomical structures in various body regions including the spine, joints, and cardiovascular system, aiding in procedures such as cardiology, orthopedics, neurology, and more. The device offers advanced digital subtraction and cine imaging, enhancing image quality and surgical navigation accuracy to improve clinical outcomes for patients.
Intended Use
The Ziehm Vision RFD is intended for providing medical imaging for adult and pediatric populations using pulsed and continuous fluoroscopic digital imaging, digital subtraction and cine image capture during diagnostic interventional and surgical procedures requiring intra-operative visualization of complex anatomical structures.
Technology
The device employs X-rays generated by a mono-block high voltage generator and an image receptor flat panel detector (FPD) integrated into a mobile C-arm system. It includes real-time image capture and post-processing capabilities with interfaces for peripheral devices and network connectivity. The system incorporates advanced software with updates including a 2k imaging chain 'QuantumStream', image overlays, and workflow integrations to enhance imaging performance and control.
Performance
Verification and validation testing were successfully conducted according to Ziehm Imaging's quality management system and FDA standards, including electrical safety, electromagnetic compatibility, and software function testing. The device complies with Federal Performance Standards for X-Ray Fluoroscopic equipment and relevant IEC standards. Cybersecurity improvements were also implemented. Testing confirmed the device is safe, effective, and performs equivalently to the predicate device K240099.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/24/2024
2 months - 2
FDA Approval
1/15/2025
Other devices from Ziehm Imaging GmbH
- Ziehm Solo FD2025 • 510K
- Ziehm Vision FD2025 • 510K
- Ziehm Vision RFD 3D2025 • 510K
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