Ziehm Vision FD

The Ziehm Vision FD is a mobile fluoroscopy system that provides real-time 2D medical imaging during diagnostic, interventional, and surgical procedures. It visualizes complex anatomical structures in vascular, cardiac, endoscopic, orthopedic, neurologic, and emergency room procedures, but does not support direct radiographic film or mammography, and is not intended for use near MRI systems.

The key modification is a software update to version 7.10.0 incorporating the 2k imaging chain 'QuantumStream' with a new 'Image Insights' overlay. In addition to the existing 8-inch IGZO flat panel detector, the modified device offers an additional IGZO panel detector; both detectors use identical Indium-Gallium-Zinc-Oxide manufacturing technology, detector size, and image quality.

21 CFR 1020.30-32 (Federal Performance Standards for X-Ray Fluoroscopic equipment); ANSI AAMI ES60601-1:2021; IEC 60601-1-2:2020; IEC 60601-1-3:2021; IEC 60601-2-43:2022; IEC 60601-2-54:2022. Testing also referenced FDA guidance on solid-state x-ray imaging devices (September 2016), pediatric x-ray imaging (November 2017), device software functions (June 2023), and cybersecurity (September 2023).

The predicate and modified device share substantially equivalent indications for use, design controls, functionality, and technology. Image quality testing with anthropomorphic and motion-induced phantoms showed the modified device's images are equal or superior in detail, detectability, and sharpness. Pediatric dose testing confirmed sufficient image quality. Software and cybersecurity testing demonstrated acceptable vulnerability profiles and no stability or security issues. All verification and validation activities confirmed device requirements are met and functionality performs as designed with no new safety or effectiveness concerns.