# K201670: YSIO X.pree

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 21, 2020 after 124 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K801623 (1980). 66 ancestors in all.
2 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)
- K181279: Ysio Max, Siemens Medi Cal Solutions, Inc. (2018). Our reading of the summary gave K181270, FDA’s number for Disposable SpO2 Sensors, Reusable SpO2 Sensors (Orantech, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ysio Max”. Summary page 6.

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

## Recalls of this device
- Mar 7, 2022 · Class II · Z-0730-2022: For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. During acquisition of each individual x-ray
- Mar 10, 2021 · Class II · Z-1346-2021: A patient image was assigned to a different patient during image recovery process. In the unlikely event of interrupted connection to a MAX detector during initiated image recovery, instead of the cur

## Indications for use
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. Generic clinical benefits of radiographic examinations within the intended use are applicable for this device. YSIO X.pree is not for mammography examinations.

Source page: https://510kreport.com/device/K201670
Methodology: https://510kreport.com/methodology