VIVIX-M
Vieworks Co., Ltd.VIVIX-M is a series of advanced flat panel detectors designed for digital mammography. These detectors capture high-quality digital X-ray images of the breast to assist clinicians in screening and diagnosing breast conditions. The system processes the X-ray signals into detailed digital images compatible with medical imaging workflows, supporting effective and accurate mammography examinations.
Intended Use
VIVIX-M detectors are flat panel detectors used in mammographic applications to acquire digital images for screening and diagnosis.
Technology
The device uses a scintillator that emits visible spectrum photons from intercepted X-ray photons, which illuminate an array of amorphous silicon photodetectors. These signals are converted to digital values by software (VXvue Mammo) that acquires, processes, and transmits images complying with DICOM standards for PACS integration.
Performance
Non-clinical performance testing including Modulation Transfer Function (MTF), Detective Quantum Efficiency (DQE), Noise Power Spectrum (NPS), Dynamic Range, Phantom Tests, and Patient Radiation Dose measurements demonstrated that the VIVIX-M detectors have equivalent imaging performance, safety, and effectiveness compared to the predicate device. Clinical image evaluation confirmed diagnostic equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/22/2024
8 months - 2
FDA Approval
1/16/2025
Other devices from Vieworks Co., Ltd.
- VIVIX-S 1751S2024 • 510K
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