# K250597: REMEX Xcam6

- Pathway: 510(k) (Traditional)
- Applicant: Remedi, Inc.
- Decided: Jul 31, 2025 after 153 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.
No later device cites it as a predicate yet.
0 of 4 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.

## Indications for use
Portable X-ray Equipment REMEX Xcam6 is intended to be used in a hospital or clinic setting under the supervision of a qualified and trained clinician. This product is used as an x-ray source to produce diagnostic x-ray images of patient's extremities using an X-ray detector. It may be used in handheld or stand-mounted configurations for acquiring diagnostic radiographic images of extremities. The device is not intended for mammography. The REMEX Xcam6 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/K250597
Methodology: https://510kreport.com/methodology