Ziehm Solo FD

The Ziehm Solo FD is a mobile fluoroscopic X-ray system for real-time medical imaging in adults and pediatric patients. It captures, stores, and displays digital fluoroscopic images and cine loops during diagnostic, interventional, and surgical procedures across multiple clinical specialties. The system does not support direct radiographic film or mammography and cannot be used in MRI environments.

The key modifications include a software update to version 7.10.0 incorporating the 2k imaging chain called 'QuantumStream' and a new 'Image Insights' overlay. In addition to the existing 8-inch IGZO flat panel detector, the modified device now offers a 12-inch IGZO panel. Both detectors use equivalent Indium-Gallium-Zinc-Oxide manufacturing technology and demonstrate equivalent image quality.

The device complies with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment and relevant safety standards including IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-43, and IEC 60601-2-54. Software testing followed FDA guidance on device software functions and cybersecurity in medical devices.

The modified Ziehm Solo FD shares substantially equivalent design controls, design, technology, functionality, and indications for use with the predicate device (K234109). Image quality testing using anthropomorphic phantoms demonstrated that the modified device produces images equal to or better than the predicate with improved details and sharpness. Cybersecurity and software testing showed acceptable vulnerability findings and good security posture. The addition of the 12-inch detector uses equivalent manufacturing technology and does not raise new safety or effectiveness concerns, therefore establishing substantial equivalence.