Wireless/ Wired X-Ray Flat Panel Detectors

The Wireless/Wired X-Ray Flat Panel Detectors are digital radiography detectors used with AWS Synergy DR software to acquire, process, display, store, and export radiographic images of all body parts for general radiographic applications. The device replaces conventional film/screen or CR systems and is not intended for mammography. It includes four portable wireless models (G4336RWC, G4343RWC, T4336RWC) and one non-portable wired model (G4343RC).

The subject device differs from its predicate in scintillator thickness (600μm vs. 400μm cesium iodide), resulting in improved DQE, MTF, and sensitivity metrics. DQE increases from 0.78-0.79 to 0.85 at 0.5 lp/mm; MTF at 0.5 lp/mm increases to 0.95 maximum; sensitivity increases to ≥801 LSB/μGy. All other specifications—pixel count, A/D conversion (16-bit), substrate materials, and software—remain unchanged from the predicate device.

Testing confirmed compliance with AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 60601-1-6, IEC 62366-1, ANSI AAMI HE75, and ISO 10993 (biocompatibility). Performance testing followed FDA guidance for Solid State X-Ray Imaging Devices (September 2016) and Device Software Functions (June 2023). EMC emission testing per IEC 60601-1-2 was performed with satisfactory results.

The thicker 600μm CsI scintillator improves image quality metrics (DQE, MTF, sensitivity) without changing the device's intended use, design, or functionality compared to the 400μm predicate. Experimental data demonstrates the thicker scintillator provides superior noise performance and smoother image quality without clinically significant degradation of detail or edges. Since only the scintillator thickness changed and this modification maintains diagnostic image quality while raising no new safety or effectiveness concerns, the device is substantially equivalent to the predicate.