# K233543: YSIO X.pree

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions
- Decided: May 21, 2024 after 200 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: 12 generations back to K801623 (1980). 67 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201670: YSIO X.pree, Siemens Medical Solutions USA, Inc. (2020) Summary page 5.

## Most influential descendants
- K250738: YSIO X.pree (2025), 0 descendants of its own

## 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/K233543
Methodology: https://510kreport.com/methodology