# K231892: Definium Pace Select

- Pathway: 510(k) (Traditional)
- Applicant: Ge Hualun Medical Systems Co., Ltd.
- Decided: Sep 12, 2023 after 76 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K862120 (1986). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172869: Discovery XR656 HD, Ge Hualun Medical Systems Co., Ltd. (2017) Summary page 5.

## Most influential descendants
- K242678: Definium Pace Select ET (2024), 0 descendants of its own

## Recalls of this device
- Jan 28, 2025 · Class II · Z-1043-2025: The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases

## Indications for use
This product is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K231892
Methodology: https://510kreport.com/methodology