Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System

The DRX-Revolution Mobile X-ray System is a portable diagnostic X-ray system designed to perform radiographic examinations on pediatric and adult patients in any patient treatment area. It incorporates three detector options: Lux HD 35/43 Detectors (high-definition flat panel detectors for general radiography), Lux HD Detectors with Digital Exposure Control (DEC), and DRX-LC Detector (a large-format wireless flat panel detector). All detectors support optional Smart Noise Cancellation (SNC) image processing software.

The modified system maintains the same fundamental components as the predicate device: x-ray generator, tube head assembly, collimator, and touchscreen interface. Key modifications include integration of new Lux HD detectors with 100μm pixel size using Cesium Iodide scintillator technology, addition of Digital Exposure Control (DEC) functionality for wireless x-ray control without physical wired connections, and optional Smart Noise Cancellation (SNC) for improved image quality with potential dose reduction. The ImageView acquisition software v2.0 received only minor GUI updates to support DEC and remains substantially unchanged.

Applicable standards include ISO 14971:2019 (risk management), IEC 60601-1-2:2015 (electromagnetic compatibility), IEC 60601-1-3:2008+A2:2021 (radiation protection), IEC 60601-2-54:2009+A1:2015 (X-ray equipment safety), IEC 62304:2006+A1:2015 (software lifecycle), ISO 10993-1:2018 (biocompatibility), and DICOM (imaging communication standards). Clinical testing included reader studies with board-certified radiologists comparing SNC-processed images to non-SNC images, with quantitative non-clinical testing using NNPS, MTF, and contrast-detail curve analysis.

The DRX-Revolution Mobile X-ray System is substantially equivalent to its predicate because it uses the same core technology, operating principles, and critical components (generator, tube, collimator, acquisition software) while integrating previously cleared Lux HD detectors (K243556) and DRX-LC detector (K230059). Clinical and non-clinical testing confirmed that DEC and SNC features do not raise new safety or effectiveness concerns; SNC images demonstrated equivalent or superior diagnostic quality compared to predicate images (p = 0.000). The system's intended use, indications, and technological characteristics are functionally equivalent to the predicate devices already cleared for general radiographic diagnosis in mobile settings.