# K181413: uDR 592h, uDR 596i

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Jun 27, 2018 after 28 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K801623 (1980). 66 ancestors in all.
2 later devices descend 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)
- K132934: Multix Select DR, Siemens Medi Cal Solutions, Inc. (2014) Summary page 4.

## Most influential descendants
- K192293: uDR 592h, uDR 596i (2019), 1 descendant of its own
- K252000: uDR Arria & uDR Aris (2025), 0 descendants of its own

## Recalls of this device
- Jan 25, 2021 · Class II · Z-1160-2021: There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.
- Feb 27, 2020 · Class II · Z-2521-2020: Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position for the standard of care. When the imag
- Jul 30, 2019 · Class II · Z-1075-2022: X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to

## 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/K181413
Methodology: https://510kreport.com/methodology