# K210479: IMPACT and X-Ranger

- Pathway: 510(k) (Special)
- Applicant: Minxray, Inc.
- Decided: Mar 19, 2021 after 28 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: 3 generations back to K040046 (2004). 3 ancestors in all.
1 later device descends 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)
- K182207: TR90BH, Minxray, Inc. (2018) Summary page 4.

## Most influential descendants
- K250750: Innovision-P5 (2025), 0 descendants of its own

## Indications for use
This is a portable X-ray system with following limitations of use: The device may be used for handheld diagnostic imaging of body extremities. The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest when used without a grid. - Not to be used on bariatric patients, unless imaging body extremities - Not for mammography use - This device is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.

Source page: https://510kreport.com/device/K210479
Methodology: https://510kreport.com/methodology