Ziehm Vision RFD 3D

The Ziehm Vision RFD 3D is a mobile fluoroscopic X-ray imaging system that provides 2D and 3D pulsed and continuous imaging for adult and pediatric patients. It assists physicians in visualizing anatomical structures during interventional, surgical, and diagnostic procedures across multiple specialties including cardiology, orthopedics, neurosurgery, and maxillofacial surgery.

The key modification is a software update to version 7.10.0 incorporating the 2k imaging chain 'QuantumStream' with a new 'Image Insights' overlay, integration of optional EndoNaut Aorta Iliac workflow, PCCplus position control, optional OR table controls, and a new 'Adult HQ' body size mode for 3D imaging with improved 3D visualization. The predicate and modified devices share substantially equivalent design controls, design, technology, and functionality.

IEC 60601-1-2 (electromagnetic compatibility), 21 CFR 1020.30-32 (federal performance standards for X-ray fluoroscopic equipment), IEC 60601-1-3 (general requirements for safety), IEC 60601-2-43 (safety standards for X-ray equipment), IEC 60601-2-54, and FDA cybersecurity requirements for medical devices.

The modified device employs identical fundamental control and substantially equivalent scientific technology as the predicate Ziehm Vision RFD 3D (K231701), with software enhancements that improve imaging chain performance and visualization capabilities. Image quality testing using anthropomorphic phantoms demonstrated that the modified device produces equal or superior image quality compared to the predicate system. Risk control assessments confirmed all device requirements were fulfilled, system functionality is consistent with user needs and intended uses, and verification/validation testing raised no new safety or effectiveness concerns.