# K181279: Ysio Max

- Pathway: 510(k) (Special)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Jun 13, 2018 after 29 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: 10 generations back to K801623 (1980). 65 ancestors in all.
3 later devices descend 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)
- K133259: Ysio Max, Siemens Medical Solutions USA, Inc. (2014) Summary page 5.

## Most influential descendants
- K201670: YSIO X.pree (2020), 2 descendants of its own
- K233543: YSIO X.pree (2024), 1 descendant of its own
- K250738: YSIO X.pree (2025), 0 descendants of its own

## Indications for use
Ysio Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Ysio Max enables radiographic and tomographic exposures of the whole body and may be used on pediatric, adult and bariatric patients. It can also be used for emergency applications. Ysio Max is not for mammography examinations.

Source page: https://510kreport.com/device/K181279
Methodology: https://510kreport.com/methodology