# K143270: Optima XR646

- Pathway: 510(k) (Traditional)
- Applicant: Ge Hualun Medical Systems Co., Ltd.
- Decided: Feb 18, 2015 after 97 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: 6 generations back to K862120 (1986). 10 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132261: Discovery XR656 with Volumerad (Digital Tomosynthesis), Ge Medical Systems, LLC (2013) Summary page 4.
- K050704: Modification to:  Revolution XR/D Digital Radiographic Imaging System with Image Pasting and Autopositioning, General Electric Co. (2005) Summary page 4.

## Most influential descendants
- K172869: Discovery XR656 HD (2017), 5 descendants of its own
- K231892: Definium Pace Select (2023), 1 descendant of its own
- K191699: Discovery XR656 HD with VolumeRad (2019), 1 descendant of its own
- K250788: Definium Tempo Select (2025), 0 descendants of its own
- K242678: Definium Pace Select ET (2024), 0 descendants of its own

## Indications for use
The Optima XR646 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 is intended for use in all routine radiography exams. The device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K143270
Methodology: https://510kreport.com/methodology