VIVIX-S 1751S
Vieworks Co., Ltd.The VIVIX-S 1751S is a digital flat panel X-ray detector designed for general-purpose diagnostic radiographic procedures. It replaces traditional film/screen X-ray systems by capturing and converting X-ray photons into digital images. This helps clinicians obtain high-quality digital X-ray images quickly and efficiently for better diagnosis.
Intended Use
The VIVIX-S 1751S series is used for general-purpose diagnostic procedures, intended to replace radiographic film/screen systems, excluding mammography applications.
Technology
The device employs a large 17x51 inch flat panel digital detector that intercepts X-ray photons using either a CsI:TI (Thallium doped Caesium Iodide) or Gadox scintillator. The scintillator converts X-rays to visible light photons, which are then detected by an array of amorphous silicon photodetectors generating electrical signals. These signals are digitized and processed by software to form X-ray images. It integrates with an external X-ray generator and PC system.
Performance
Performance testing included comparison of Modulation Transfer Function (MTF), Detective Quantum Efficiency (DQE), and spatial resolution metrics between the subject and predicate devices, demonstrating similar performance. A Qualified Expert Evaluation confirmed the device provides images with equivalent diagnostic capability to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/23/2024
6 months - 2
FDA Approval
11/15/2024
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