# K173612: Optima XR646 HD

- Pathway: 510(k) (Special)
- Applicant: Ge Hualun Medical Systems Co., Ltd.
- Decided: Dec 11, 2017 after 19 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.
No later device cites it as a predicate yet.
0 of 13 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 4.

## Recalls of this device
- Jan 28, 2025 · Class II · Z-1046-2025: 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
The Optima XR646 HD 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. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. The device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K173612
Methodology: https://510kreport.com/methodology