# K243864: BONX805

- Pathway: 510(k) (Traditional)
- Applicant: Bontech Co., Ltd.
- Decided: Sep 12, 2025 after 269 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)
- K212144: Remex KA6, Remedi Co., Ltd. (2021) Summary page 5.

## Indications for use
The BONX805 is a portable X-ray system for diagnostic imaging of body extremities.

Source page: https://510kreport.com/device/K243864
Methodology: https://510kreport.com/methodology