# K250738: YSIO X.pree

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions
- Decided: Jul 31, 2025 after 142 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K801623 (1980). 68 ancestors in all.
No later device cites it as a predicate yet.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233543: YSIO X.pree, Siemens Medical Solutions (2024) Summary page 6.

## Indications for 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. The device is a digital X-ray system to generate X-ray images from the whole body including the skull, chest, abdomen, and extremities. The acquired images support medical professionals to make diagnostic and/or therapeutic decisions. YSIO X.pree is not for mammography examinations.

Source page: https://510kreport.com/device/K250738
Methodology: https://510kreport.com/methodology