MC2 Portable X-ray System

The MC2 Portable X-ray System is a handheld, battery-powered X-ray device designed for point-of-care radiographic imaging of extremities distal to the shoulders and knees in adult patients. It consists of an emitter and cassette that interface wirelessly with a tablet or monitor via the OXOS Device App, and supports three imaging modes: single radiography, serial radiography, and fluoroscopy. The device includes safety features such as LIDAR-based source-to-skin distance monitoring and infrared tracking for proper alignment.

The MC2 uses an iRay Mercu0909X detector (9×9 inches, 5 fps) versus the predicate's 12×12 inch detector at 20 fps; both employ cesium iodide scintillators and LIDAR for source-to-skin distance control. The MC2 has a slightly higher resolution pixel pitch (139 μm vs. 145 μm), larger focal spot (0.8 vs. 0.6), and longer exposure times (40–200 ms vs. 10 ms). MTF and DQE values are similar between devices. Both support single and fluoroscopic imaging modes with comparable kVp ranges (40–80 kVp for MC2 vs. 30–80 kVp for predicate).

Compliance demonstrated with IEC 60601-1 (general safety), IEC 60601-1-3 (radiation protection), IEC 60601-2-54 (radiography and radioscopy), IEC 60601-2-43 (interventional procedures), IEC 60601-2-28 (X-ray tube assemblies), IEC 62304 (software lifecycle), ISO 14971 (risk management), and 21 CFR 1020.30–1020.32 (diagnostic X-ray system requirements). DICOM 3.0 compliance and cybersecurity threat modeling per FDA guidance were also verified.

The MC2 shares core technological principles and design features with the predicate Virtual C DRF, including fluoroscopic and radiographic imaging modes, identical scintillator material, identical LIDAR-based source-to-skin distance control, and similar MTF/DQE performance. Although the MC2 has a smaller detector and narrower anatomical scope (extremities only, not surgery), these differences do not raise new safety or effectiveness concerns; comprehensive bench testing and a clinical image quality study involving five radiologists confirmed adequate imaging performance for the stated orthopedic indications. The safety interlocks, electrical standards compliance, and software controls are equivalent or exceed the predicate device.