# K250750: Innovision-P5

- Pathway: 510(k) (Traditional)
- Applicant: Dk Medical Systems Co., Ltd.
- Decided: Jul 18, 2025 after 128 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: 4 generations back to K040046 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210479: IMPACT and X-Ranger, Minxray, Inc. (2021) Summary page 5.

## Indications for use
The portable x-ray system may be used for diagnostic imaging of 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/K250750
Methodology: https://510kreport.com/methodology