# K252000: uDR Arria & uDR Aris

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Nov 26, 2025 after 152 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: 13 generations back to K801623 (1980). 68 ancestors in all.
No later device cites it as a predicate yet.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192293: uDR 592h, uDR 596i, Shanghai United Imaging Healthcare Co., Ltd. (2019) Summary page 6.

## Indications for use
Digital Medical X-ray Imaging System 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/K252000
Methodology: https://510kreport.com/methodology