# K183388: JADE Mobile X-Ray

- Pathway: 510(k) (Traditional)
- Applicant: DRGEM Corporation
- Decided: Feb 5, 2019 after 61 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: 8 generations back to K981556 (1998). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182317: AMADEO M-DR mini, AMADEO M-AX mini, Oehm Und Rehbein GmbH (2018) Summary page 4.

## Indications for use
The JADE Mobile X-Ray, is a mobile X-ray device, for the purpose of acquiring X-ray images of the desired parts of a patient’s anatomy. This device is not intended for mammography, bone density, or dedicated pediatric applications.

Source page: https://510kreport.com/device/K183388
Methodology: https://510kreport.com/methodology