Ziehm Vision RFD 3D
Ziehm Imaging GmbHThe Ziehm Vision RFD 3D is a medical imaging device that provides high-quality 2D and 3D fluoroscopic X-ray images during surgical and diagnostic procedures. It helps clinicians visualize complex anatomical structures such as bones, joints, and soft tissues in real-time, improving outcomes in orthopedic, neurological, trauma, and other surgeries. The system supports computer-assisted surgery by providing detailed imaging and C-arm positioning data, facilitating safer and more accurate interventions.
Intended Use
The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations, including visualization of complex anatomical structures intra-operatively in diverse fields such as orthopedics, neurology, cardiology and interventional procedures.
Technology
The device consists of two physical elements: a C-Arm with a wheeled base providing X-ray image data using pulsed and continuous fluoroscopy, and a Monitor Cart for real-time visualization. It incorporates an updated software version 7.10.0 with a 2k imaging chain 'QuantumStream' and new image overlay 'Image Insights' for improved 3D visualization and integration with optional workflows and table controls.
Performance
Verification and validation testing demonstrated compliance with FDA requirements and standards including IEC 60601 and federal performance standards for fluoroscopy. Image quality tests using anthropomorphic phantoms showed equal or improved image clarity and detectability compared to predicate devices. Software and cybersecurity testing were also successfully performed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/21/2024
3 months - 2
FDA Approval
1/21/2025
Other devices from Ziehm Imaging GmbH
- Ziehm Solo FD2025 • 510K
- Ziehm Vision FD2025 • 510K
- Ziehm Vision RFD2025 • 510K
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