Ziehm Vision RFD

The Ziehm Vision RFD is a mobile fluoroscopy system for intra-operative medical imaging in adult and pediatric patients. It uses X-rays to visualize anatomy during diagnostic and surgical procedures including interventional cardiology, orthopedic surgery, neurosurgery, and emergency procedures. The system consists of a C-arm mobile stand with flat panel detector and a monitor cart workstation for image display and processing.

The modified device incorporates software version 7.10.0 with the 2k imaging chain QuantumStream and Image Insights overlay. It adds support for optional EndoNaut Aorto Iliac workflow integration, PCCplus position control, and optional OR table controls. In addition to the existing 12-inch IGZO flat panel detector, the modified version now offers an 8-inch IGZO panel option.

ANSI/AAMI ES60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54 (safety standards), and 21 CFR 1020.30-32 (Federal Performance Standards for X-Ray Fluoroscopic equipment). Software testing followed FDA guidance on device software functions.

The predicate and modified devices share identical indications for use, substantially equivalent design controls, and identical intended use. The modifications are software enhancements (version 7.10.0) and hardware options (8-inch detector) that do not change fundamental X-ray imaging technology or safety profile. Verification and validation testing confirmed device requirements were met and system functionality performs as designed with no new safety or effectiveness concerns raised compared to the predicate K240099.