DRX-Revolution Mobile X-ray System

The DRX-Revolution Mobile X-ray System is a mobile diagnostic x-ray device designed to perform radiographic examinations on pediatric and adult patients in various treatment areas. It consists of an x-ray generator, tube head assembly, maneuverable drive system, and touchscreen interfaces for acquiring and processing medical diagnostic images outside standard stationary x-ray rooms.

The modified device uses the same fundamental technology and operating principles as the predicate (K191025), including the same x-ray generator, tube, collimator, and ImageView software. New features include Smart Noise Cancellation (SNC), Align Assist for workflow optimization, Inching for cart movement, compatibility with the Lux 35 detector, and ImageView V2.0 (upgraded from V1.0). Design improvements were made to generator components, tube head handles, covers, and cord reel, though component-level functionality remains equivalent to the predicate.

ISO 14971:2019, ISO 20471:2021, IEC 62366-1:2015+A1:2020, ISO 15223-1:2021, AAMI ES60601-1:2005+C1;A2:2012, IEC 60601-1-2:2015, IEC 60601-1-3:2008+A2:2021, IEC 60601-1-6:2010+A1:2015, IEC 60601-2-54:2009+A1:2015, IEC 60601-2-28:2017, IEC 62304:2006+A1:2015, ISO 10993-1:2018, and DICOM.

The device achieves substantial equivalence through identical fundamental technology, critical components, and intended use compared to the predicate. New features like SNC produce identical image output validated through pixel-by-pixel analysis showing 99% of pixels within ±1 pixel value. New features (Align Assist, Inching) are operational improvements with no impact on imaging performance, and compatibility with additional detectors does not affect image quality. Design component improvements maintain the same functionality as the predicate, and verification/validation testing demonstrates safety and performance equivalence.