Ziehm Solo FD
Ziehm Imaging GmbHThe Ziehm Solo FD is a mobile fluoroscopic X-ray imaging device designed for both adult and pediatric patients. It provides real-time pulsed and continuous fluoroscopic imaging to assist clinicians during diagnostic, interventional, and surgical procedures across various specialties such as orthopedics, neurology, vascular, and cardiac care. The device enhances visualization of anatomical structures, helping improve clinical outcomes through high-quality digital images and cine loops capture.
Intended Use
The Ziehm Solo FD is intended for use in providing medical imaging for adults and pediatric populations, using pulsed and continuous fluoroscopic imaging during diagnostic, interventional, and surgical procedures.
Technology
The device uses an X-ray tube in a mono-block generator housing that produces X-rays penetrating the patient, with a special flat panel detector converting X-rays into digital images. It includes an advanced heat management system, CAN BUS system control, and a mechanical C-Profile supporting the generator, flat panel detector, and a laser positioning device. Software improvements introduced a 2k imaging chain called QuantumStream and an Image Insights overlay, with detector sizes of 8-inch and 12-inch IGZO flat panels.
Performance
The device underwent verification and validation testing under quality management systems and complies with federal performance standards for X-ray fluoroscopic equipment and relevant IEC safety standards. Image quality testing using anthropomorphic and motion phantoms demonstrated the device produces images equal to or better than the predicate device, with sharper details and improved detectability. Software and cybersecurity testing, including vulnerability scanning, penetration testing, and static code analysis, showed the device has a good cybersecurity posture and complies with FDA requirements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/26/2024
3 months - 2
FDA Approval
3/17/2025
Other devices from Ziehm Imaging GmbH
- Ziehm Vision FD2025 • 510K
- Ziehm Vision RFD 3D2025 • 510K
- Ziehm Vision RFD2025 • 510K
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