Yushan X-Ray Flat Panel Detector
InnoCare Optoelectronics Corp.The Yushan X-Ray Flat Panel Detector is a digital radiography detector that captures high-quality X-ray images of the human anatomy for general projection radiographic use. It helps healthcare professionals obtain clear images quickly and efficiently, suitable for many standard imaging applications except mammography, fluoroscopy, tomography, and angiography. The device supports wired and wireless operation and includes software for image processing and workflow management, facilitating smoother clinical integration and better patient care.
Intended Use
The Wireless (V14C, V14G, F14C, F14G, V17C, V17G)/Wired (V14C, V14G, F14C, F14G, V17C, V17G, V17Ge, V17Ce) Yushan X-Ray Flat Panel Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector is not intended for mammography, fluoroscopy, tomography, and angiography applications. The use of this product is not recommended for pregnant women and the risk of radioactivity must be evaluated by a physician.
Technology
Yushan X-Ray Flat Panel Detector is a solid-state digital X-ray imager available in both wireless and wired models, designed to replace radiographic cassettes. It includes a rounded-edge design for easy handling, image compression for fast transfer, LED detector identification, and protection against water ingress. It operates via software (Xresta on Windows PC and DR Console app) managing detector status, x-ray exposure, image viewing and measurement, image processing, and DICOM integration. Software is assessed as having a basic level of concern with cybersecurity risks addressed in design.
Performance
The device complies with multiple voluntary and regulatory standards including IEC 60601 series and ISO 10993 biocompatibility. Non-clinical performance evaluated includes EMC emissions, load-bearing, ingress protection, and image quality equivalence to predicate devices. Clinical performance was not performed; equivalence was shown by non-clinical data and software validation. Cybersecurity and usability for operation systems (iOS 16 or above for the app) were also validated.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/30/2024
2 months - 2
FDA Approval
12/19/2024
Other devices from InnoCare Optoelectronics Corp.
- Yushan X-Ray Flat Panel Detector2025 • 510K
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