# K170607: !M1

- Pathway: 510(k) (Traditional)
- Applicant: Solutions For Tomorrow AB
- Decided: Jul 17, 2017 after 138 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: 2 generations back to K041763 (2004). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120062: DRX-Revolution Mobile X-Ray System, Carestream Health, Inc. (2012) Summary page 5.

## Most influential descendants
- K241980: !M1 (2025), 1 descendant of its own
- K251710: Mobile X-ray unit (!M1) (2025), 0 descendants of its own

## 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/K170607
Methodology: https://510kreport.com/methodology