# K222339: uDR 380i Pro

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Sep 30, 2022 after 58 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 K041763 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191025: DRX-Revolution Mobile X-ray System, Carestream Health, Inc. (2019) Summary page 4.

## Most influential descendants
- K242515: uDR 380i Pro (2024), 0 descendants of its own

## Indications for use
uDR 380i Pro is a mobile digital radiography device intended to acquire X-ray images of the human anatomy for medical diagnosis. uDR 380i Pro can be used on both adult and pediatric patient by a qualified and trained operator. This device is not intended for mammography.

Source page: https://510kreport.com/device/K222339
Methodology: https://510kreport.com/methodology