Orthoscan VERSA Mini C-Arm

The Orthoscan VERSA Mini C-Arm is a mobile fluoroscopic X-ray system designed to provide general fluoroscopic visualization for diagnostic, surgical, and emergency care procedures on patients of all ages, including pediatric populations. It is used for imaging limbs, extremities, and shoulders in hospitals, ambulatory surgery centers, emergency departments, and physician offices.

The VERSA Mini C-Arm retains identical function to predicate devices but incorporates a Linux operating system upgrade from Ubuntu 16.04 to 20.04 for improved cybersecurity, mechanical design modifications to facilitate desktop use, revised generator printed circuit board for improved power management, alternate radiation shielding material to reduce lead environmental impact, and updated wireless footswitch communication from fixed pairing to code-hopping protocol. All core features remain unchanged: C-arm support, flat panel detector, generator, X-ray controls, workstation platform, touch screen interface, and DICOM network interfaces.

The device was tested by certified laboratory and is compliant with IEC 60601-1 ED 3.2 series including IEC 60601-2-54, and meets all applicable sections of 21 CFR Subchapter J performance standards for X-ray imaging devices.

The proposed modifications do not change the control mechanism, operating principle, energy type, or intended use compared to predicate devices Orthoscan TAU Mini C-Arm (K213113) and Orthoscan Mobile DI (K113708). Non-clinical testing with anthropomorphic phantoms and radiologist assessment demonstrated image quality at same or similar patient dose rates results in equivalent or slight improvement. Usability testing confirmed no previously unknown use errors or hazardous situations and no unacceptable residual risks from user interface changes.