YSIO X.pree
Siemens Medical SolutionsYSIO X.pree is a modular digital X-ray system designed to visualize anatomical structures across the whole body, including the skull, chest, abdomen, and extremities. It helps clinicians by producing high-quality X-ray images that support diagnosis and therapy decisions. The system features updated hardware and software, including a new wireless detector and AI-based auto-cropping and collimation capabilities, enhancing workflow efficiency and image quality.
Intended Use
To visualize anatomical structures of human beings by converting an X-ray pattern into a visible image. Generates digital X-ray images from the whole body including skull, chest, abdomen, and extremities to support diagnostic and/or therapeutic decisions.
Technology
Modular stationary X-ray system with components including ceiling suspension with X-ray tube, Bucky wall stand/table, updated X-ray generator, portable wireless and fixed integrated detectors, and a new X.wi-D 24 portable wireless detector. AI-based auto-cropping and virtual automatic exposure control selection are also included.
Performance
Non-clinical testing per voluntary standards for safety, performance, and usability was conducted. A clinical customer use test confirmed system stability, usability, and image quality. The new wireless detector was evaluated by a board-certified radiologist and images were deemed adequate for radiography.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/11/2025
4 months - 2
FDA Approval
7/31/2025
Other devices from Siemens Medical Solutions
- YSIO X.pree2024 • 510K
- syngo.CT Lung CAD2020 • 510K
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