YSIO X.pree
Siemens Medical SolutionsYSIO X.pree is a digital stationary X-ray system designed to create X-ray images of various body parts including the skull, chest, abdomen, and extremities. It helps medical professionals visualize anatomical structures to support diagnosis and treatment. The system features updated software, new wireless detectors, and AI-based functions like auto-cropping and automatic collimation to improve image quality and ease of use.
Intended Use
The intended use of the device YSIO X.pree is to visualize anatomical structures of human beings by converting an X-ray pattern into a visible image. It generates X-ray images from the whole body including the skull, chest, abdomen, and extremities to support medical professionals in making diagnostic and/or therapeutic decisions.
Technology
YSIO X.pree is a modular digital X-ray system with components like ceiling suspension, X-ray tube, wall stand, table, X-ray generator, wireless and fixed integrated detectors. It incorporates AI-based software features such as auto-cropping and automatic collimation (long-leg/full-spine), and uses updated detectors and camera model for improved performance.
Performance
The device underwent clinical use testing, non-clinical performance testing including compliance with multiple IEC standards (e.g. IEC 60601 series), usability testing, risk analysis, and integration testing. Clinical testing confirmed image quality, system functionality, ease of use, and overall performance met intended use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/3/2023
6 months - 2
FDA Approval
5/21/2024
Other devices from Siemens Medical Solutions
- syngo.CT Lung CAD2020 • 510K
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