2430TCA with Xmaru W
Rayence Co., LtdThe 2430TCA with Xmaru W is a digital flat panel X-ray detector system designed for mammographic screening. It replaces traditional film or screen-based mammographic systems by capturing and digitizing high-quality breast images, assisting clinicians in breast cancer screening with enhanced image quality and reduced noise.
Intended Use
The 2430TCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for a mammographic system. It is intended to replace film or screen based mammographic systems in screening mammography. Xmaru W is an integrated software solution indicated for use with the 2430TCA detector.
Technology
The 2430TCA is a digital mammography X-ray detector based on flat-panel technology with a CsI scintillator coupled to a TFT sensor. It digitizes X-ray images for mammographic screening and connects to a viewing station via LAN. The software, Xmaru W, processes RAW files into DICOM compatible images.
Performance
Performance testing demonstrated substantial equivalence to predicate device K202902 with similar image quality and improved parameters such as less noise and better contrast. Testing included clinical reviews by MQSA-certified radiologists and non-clinical tests (MTF, DQE, NPS) per IEC standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/16/2024
2 months - 2
FDA Approval
3/12/2025
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