Yushan X-Ray Flat Panel Detector

The Yushan X-Ray Flat Panel Detector is a static digital x-ray detector available in portable (wireless/wired) and non-portable (wired) models. It captures and displays radiographic images of human anatomy for general projection radiography applications as a replacement for conventional film/screen or CR systems. The device is not intended for mammography, fluoroscopy, tomography, or angiography.

The subject device uses a thicker cesium iodide (CsI) scintillator (600 μm) compared to the predicate's 400 μm thickness, resulting in higher Detective Quantum Efficiency (DQE of 0.60 @ 1 lp/mm vs. 0.48), slightly lower Modulation Transfer Function (MTF of 0.64 vs. 0.69 @ 1 lp/mm), and higher sensitivity (715 lsb/uGy). All other characteristics including circuit design, operating principle, software (DROC, Xresta, DR Console), and mechanical design remain unchanged from the predicate devices.

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 series for biocompatibility, and IEC 60601-1-2 for EMC emission testing.

The thicker CsI scintillator provides superior signal-to-noise ratio and smoother image quality (higher DQE) without clinically significant degradation of spatial resolution or edge detail (MTF remains comparable to GOS models and only slightly lower than the CsI predicate). Since the scintillator thickness change only affects image quality metrics (DQE, MTF, sensitivity) and does not alter the intended use, indications, safety profile, or operating principle, and the device meets the same performance standards as the predicate, no new safety or effectiveness concerns are introduced.