MasteRad MiniX Mobile Digital Imaging System (Mini-X)

The MasteRad MiniX (Mini-X) is a mobile fluoroscopic x-ray system designed for real-time imaging guidance during diagnostic radiography and surgical procedures of the extremities. It is intended for use by qualified healthcare professionals in various healthcare settings and can be positioned with patients sitting, standing, or in prone/supine positions; it excludes neonates and mammography applications.

The Mini-X uses a flat-panel detector with Indium Zinc Gallium Oxide (IZGO) substrates, a low-powered mono-block x-ray generator, and a dynamic flat-panel detector enabling operation from a standard 120VAC outlet. Key differences from the predicate include a fixed 50 cm source-to-image distance (versus predicate's 100 cm), higher spatial resolution for extremity detail, and the DRTECH EXPD 2430P detector (versus the predicate's different detector model), though both share similar IZGO technology.

IEC 60601-1-3:2008+A1:2013, IEC 60601-2-54:2022, IEC 60601-2-43:2022, and 21 CFR 1020.32. Bench testing included phantom image comparisons and dose analysis; compliance with electrical, mechanical, and radiation safety standards was demonstrated.

The Mini-X achieves substantial equivalence through identical indications for use (real-time fluoroscopic imaging for extremity procedures) and shared technological principles with the predicate VFSS Pro Mobile Digital Imaging System. Although design differences exist—reduced source-to-image distance, lower-powered generator, and enhanced spatial resolution—these do not raise new safety or effectiveness concerns because bench testing and phantom comparisons demonstrated equivalent imaging performance, and the reduced SID compensates for the lower power while maintaining adequate detector entrance doses. Compliance with the same applicable standards further supports equivalence.