Digital Radiographic Imaging Acquisition Software - DR (RiasDR)

RiaspDR is radiographic imaging acquisition software that directly controls and acquires general radiographic images of human anatomy (excluding fluoroscopic, angiographic, dental, and mammographic applications) from the Mars1417X digital X-ray detector. The software performs image viewing, searching, storage, annotation, measurement, and processing while complying with DICOM standards and interfacing with PACS systems.

The subject device includes wireless connectivity via TCP/IP or WiFi for detector communication, whereas the predicate device (Econsole1) did not have wireless capability. Both devices support the same core functions: image viewing, search, storage, annotation, measurement, and processing. Both use digital X-ray detectors, are DICOM 3.0 compatible, and fall under the same regulatory classification and product code (LLZ, 21 CFR 892.2050).

Software Verification and Validation testing was performed in accordance with FDA guidance on Content of Premarket Submissions for Device Software Functions (June 14, 2023), Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (September 27, 2023), and the Digital Imaging and Communications in Medicine (DICOM) Set standard.

The device is substantially equivalent because it shares the same regulatory classification, product code, intended use (general radiographic imaging), and core software functions with the predicate Econsole1 device. Both devices perform identical image management and processing operations on digital X-ray detector data and maintain DICOM 3.0 compatibility. The addition of wireless connectivity represents a minor feature enhancement that does not alter the fundamental intended use or safety profile, and verification testing confirmed the device meets predetermined acceptance criteria consistent with the predicate's performance.