# K212144: Remex KA6

- Pathway: 510(k) (Traditional)
- Applicant: Remedi Co., Ltd.
- Decided: Aug 3, 2021 after 25 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.
3 later devices descend from it; 3 cite it directly.
0 of 7 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 5.

## Most influential descendants
- K243864: BONX805 (2025), 0 descendants of its own
- K243473: Prorad Atlas Ultraportable; Prorad Atlas Ultraportable Plus (2025), 0 descendants of its own
- K213405: MINE ALNU (Model: Mine 2.1) (2022), 0 descendants of its own

## Indications for use
The KAG6 is a portable X-ray system for diagnostic imaging of body extremities.

Source page: https://510kreport.com/device/K212144
Methodology: https://510kreport.com/methodology