ExamVue Apex
JPI Healthcare Co, LtdExamVue Apex is a flat panel digital X-ray detector system designed for use in general and specialist radiology, including mobile x-ray systems. It captures digital images by converting x-rays to electronic signals, facilitating efficient image acquisition and management without film. The system includes advanced software for image processing, presentation, and storage, helping clinicians to acquire high-quality diagnostic images effectively.
Intended Use
The ExamVue Apex flat panel x-ray detector system is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems. The system is not for use in mammography.
Technology
ExamVue Apex consists of wired or wireless amorphous silicon flat panel detectors with cesium iodide scintillators that convert x-rays into electronic signals. It includes ExamVue Duo software for image acquisition, processing, presentation, and storage in DICOM format. The device supports multiple panel sizes and provides tools for measurement and image viewing.
Performance
The device underwent electrical safety, electromagnetic compatibility, and performance testing according to international standards (IEC). Bench testing demonstrated equivalent or superior imaging characteristics compared to the predicate device, with clinical evaluations confirming image quality adequacy by a certified radiologist. Software was validated as moderate risk with testing compliant with FDA software guidance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/26/2024
2 months - 2
FDA Approval
2/24/2025
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