# K192293: uDR 592h, uDR 596i

- Pathway: 510(k) (Special)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Sep 12, 2019 after 20 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: 12 generations back to K801623 (1980). 67 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181413: uDR 592h, uDR 596i, Shanghai United Imaging Healthcare Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K252000: uDR Arria & uDR Aris (2025), 0 descendants of its own

## Indications for use
The uDR 592h, uDR596i Radiographic system is intended to use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk .Not for mammography.

Source page: https://510kreport.com/device/K192293
Methodology: https://510kreport.com/methodology