YSIO X.pree

The YSIO X.pree is a digital radiography X-ray system designed to visualize anatomical structures by converting X-ray patterns into visible images. It generates X-ray images of the whole body including skull, chest, abdomen, and extremities to support medical professionals in making diagnostic and therapeutic decisions. The device is not intended for mammography examinations.

The subject device incorporates an updated Polydoros RFX generator, updated Digital Multileaf Collimator RFU, updated patient table and Bucky wall stand, a new X.wi-D 24 portable wireless detector, virtual AEC selection capability, and new status indicator lights. The X-ray tube, imaging detectors, software platform (syngo XR), and core operating principles remain substantially the same as the predicate device.

The device was tested against IEC 60601-1 (medical electrical equipment safety), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-1-3 (radiation protection), IEC 60601-2-54 (X-ray equipment for radiography), IEC 62366-1 (usability engineering), ISO 14971 (risk management), IEC 62304 (software lifecycle), and NEMA PS 3.1-3.20 (DICOM imaging standards).

The subject device maintains the same regulatory classification (21 CFR 892.1680, Class II), product code (KPR), and intended use as the predicate. Although hardware components were updated (generator, collimator, table, wall stand) and new features added (wireless detector X.wi-D 24, virtual AEC, status lights), these modifications do not alter the fundamental technology or operating principles. Clinical testing confirmed image quality and system performance met intended use requirements, and the new detector's specifications and performance characteristics match or exceed predicate detector performance.