0909FCE, 0909FCE-HS
Rayence Co., Ltd.The 0909FCE and 0909FCE-HS are digital flat-panel X-ray detectors designed to replace traditional film-based radiographic systems. They help physicians and healthcare professionals capture high-quality digital images of various body parts (like head, neck, spine, arms, and legs) to aid in diagnosis and treatment planning. These devices are not intended for mammography.
Intended Use
Indicated for digital imaging solution designed including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). Intended to replace film-based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.
Technology
Digital solid-state X-ray detectors using a scintillator (Cesium Iodide) coupled to Indium Gallium Zinc Oxide (IGZO) on a TFT sensor, connected via wired LAN to a PC, and capable of converting RAW images to DICOM format. Includes updated image processing and generator integration compared to predicate device.
Performance
Both clinical and non-clinical tests, including MTF, DQE, and NPS performance, showed that 0909FCE and 0909FCE-HS are equivalent or superior to the predicate in diagnostic image quality. Software validation confirmed intended function and risk mitigation for updated features. Testing performed per IEC 62220-1, IEC 60601-1, IEC 60601-1-2, and relevant FDA guidance.
Predicate Devices
No predicate devices specified
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