# K251167: uDR Aurora CX

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Sep 19, 2025 after 157 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K981556 (1998). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241068: uDR 780i, Shanghai United Imaging Healthcare Co., Ltd. (2024) Summary page 5.

## Indications for use
uDR Aurora CX is intended to acquire X-ray images of the human body by a qualified technician, examples include acquiring two-dimensional X-ray images of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. The visualization of such anatomical structures provide visual evidence to radiologists and clinicians in making diagnostic decisions. This device is not intended for mammography.

Source page: https://510kreport.com/device/K251167
Methodology: https://510kreport.com/methodology