Yushan X-Ray Flat Panel Detector

The Yushan X-Ray Flat Panel Detector is a portable or non-portable radiographic imaging device designed to capture and display X-ray images of human anatomy. It is intended for general projection radiography applications as a replacement for conventional film/screen or CR (computed radiography) systems, but is not intended for mammography, fluoroscopy, tomography, or angiography.

The device maintains identical dimensions, weight, pixel pitch (140 μm), scintillator materials (GOS or CsI), substrate types (glass or polyethylene terephthalate laminate), and image quality metrics (DQE, MTF, resolution) across all models compared to predicate devices K201528, K210988, and K220510. Key specifications include 16-bit A/D conversion, Gigabit Ethernet wired interface with optional IEEE 802.11 wireless connectivity, and rechargeable lithium battery power for portable models.

AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 60601-1-6, ANSI AAMI IEC 62366-1, ANSI/AAMI HE75, ISO 10993 (biocompatibility), and IEC 60601-1-2 (EMC testing). FDA guidance documents on solid-state X-ray imaging devices, device software functions, and medical device cybersecurity were also followed.

The subject device has identical indications for use, technical specifications, dimensional characteristics, image quality performance metrics, and material composition as multiple previously-cleared predicate devices from the same manufacturer. The only modifications are two new user interface options (Xresta software and DR Console app) which both underwent basic-level software evaluation and cybersecurity risk analysis, with all functions confirmed to operate normally without introducing new safety or effectiveness concerns. Image quality evaluation confirmed substantial equivalence to the predicate device.