YSIO MAX is a modular stationary X-ray imaging system designed for hospitals and clinics. It enables full-body radiographic and tomographic exposures and supports various patient positions. The system includes integrated and portable digital detectors that convert X-rays into diagnostic electronic images. It helps clinicians by offering efficient positioning and image processing, including optional AI-based soft tissue enhancement for chest X-rays, facilitating more accurate and timely diagnosis.
Intended Use
The Ysio Max is a radiographic system used for radiographic and tomographic exposures of the whole body including skull, chest, abdomen, and extremities. It is used on pediatric, adult, and bariatric patients and supports intravenous, small interventions, and emergency applications.
Technology
Modular X-ray system with components such as ceiling suspension with X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable and fixed integrated digital detectors. Includes new detector sizes with wireless options and enhanced system control software enabling simultaneous multi-axis movements. Optional AI-based image processing (Riverain ClearRead) provides enhanced soft tissue imaging for digital chest X-rays.
Performance
Non-clinical software integration and functional tests were conducted with risk analyses and mitigations. Electrical and mechanical safety conform to standards. No new clinical testing was required due to unchanged indications and applications. Testing supports equivalence in safety and effectiveness compared to predicate device Ysio.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/23/2013
3 months - 2
FDA Approval
1/24/2014
Other devices from SIEMENS MEDICAL SOLUTIONS USA, INC.
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