MC2 Portable X-ray System

The MC2 Portable X-ray System is a handheld and stand-mounted image-intensified fluoroscopic x-ray device designed for point-of-care orthopedic imaging of extremities in adult and pediatric patients. It supports single radiography, serial radiography, and fluoroscopy modes, and is intended for use in healthcare facilities by qualified medical professionals for diagnostic and interventional procedures.

The MC2 shares identical technological characteristics with its predicate device (K241567), including the same detector (iRay Mercu0909X, 9×9 in, 5 fps), source-to-image distance (25–80 cm), kVp range (40–80 kVp), mA range (1.0–2.0 mA), collimator design, software architecture, and connectivity options. The device utilizes LIDAR for source-to-skin distance monitoring and infrared tracking for emitter positioning.

The device complies with electrical safety standards including IEC60601-1:2005 + A2 (2020) and IEC60601-1-2:2020. Testing included cybersecurity assessment per FDA guidance using STRIDE threat modeling, penetration testing, image quality studies for pediatric populations and additional anatomies, and usability validation studies with 15 participants.

The subject MC2 is substantially equivalent to the predicate device (K241567) because it has identical product codes, regulation, classification, design, and technological specifications. The modifications expand the indications to include pediatric use, imaging of shoulders and knees in stand-mounted configuration, and handheld serial radiography for distal extremities—all supported by comprehensive performance testing, clinical image quality studies, and reference devices that cover these indications.