# K191699: Discovery XR656 HD with VolumeRad

- Pathway: 510(k) (Traditional)
- Applicant: Ge Hualun Medical Systems Co., Ltd.
- Decided: Jul 24, 2019 after 29 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: 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)
- K132261: Discovery XR656 with Volumerad (Digital Tomosynthesis), Ge Medical Systems, LLC (2013) Summary page 4.
- K172869: Discovery XR656 HD, Ge Hualun Medical Systems Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K250788: Definium Tempo Select (2025), 0 descendants of its own

## Recalls of this device
- Jan 28, 2025 · Class II · Z-1044-2025: 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
- Nov 7, 2023 · Class II · Z-0552-2024: GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of el
- Nov 7, 2023 · Class II · Z-0553-2024: GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of el

## Indications for use
The Discovery XR656 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 Discovery XR656 HD incorporates AutoGrid, which is an optional image processing software installed as a part of the systems Helix image processing software. AutoGrid can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation. When the VolumeRAD option is included on the system, the system can generate tomographic images of human anatomy including the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. When the VolumeRAD option is used for patients undergoing thoracic imaging, it is indicated for the detection of lung nodules. VolumeRad generates diagnostic images of the chest that aid the radiologist in achieving superior detectability of lung nodules versus posterior-anterior and left lateral views of the chest, at a comparable radiation level. The device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K191699
Methodology: https://510kreport.com/methodology