# K251710: Mobile X-ray unit (!M1)

- Pathway: 510(k) (Traditional)
- Applicant: Solutions For Tomorrow AB
- Decided: Oct 24, 2025 after 143 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- 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 K981556 (1998). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241980: !M1, Solutions For Tomorrow AB (2025) Summary page 6.

## Indications for use
The device is designed to perform general radiography x-ray examinations on all pediatric and all adult patients, in all patient treatment areas. Treatment areas are defined as professional health care facility environments where operators with medical training are continually present during patients' examinations.

Source page: https://510kreport.com/device/K251710
Methodology: https://510kreport.com/methodology