510(k) · Cleared
Recalled · Class II · 2025Discovery XR656 HD with VolumeRad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Hualun Medical Systems Co., Ltd. · KPR System, X-Ray, Stationary
Cleared on Jul 24, 2019 as substantially equivalent to K132261 (Ge Medical Systems, LLC, 2013) and 1 other predicate after a 29-day review. Its family tree reaches back 8 generations to 1986. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Jul 24, 2019
- Review
- 29 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 8 generations to K862120 (1986). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 7 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 6 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 5 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 4 generations backK042602 Revolution XR/D Digital Radiographic Imaging System with Manual…Ge Medical Systems, LLC · 2005
- 3 generations backK050704 Modification to: Revolution XR/D Digital Radiographic Imaging System…General Electric Co. · 2005 · Recalled
- 2 generations backK143270 Optima XR646Ge Hualun Medical Systems Co., Ltd. · 2015
- 1 generation backK172869 Discovery XR656 HDGe Hualun Medical Systems Co., Ltd. · 2017 · Recalled
- This deviceK191699 Discovery XR656 HD with VolumeRadGe Hualun Medical Systems Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK250788 Definium Tempo SelectGe Hualun Medical Systems Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250788Definium Tempo SelectGe Hualun Medical Systems Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −7 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −6 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −5 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −4 | K042602 | Revolution XR/D Digital Radiographic Imaging System with Manual Image Pasting | Ge Medical Systems, LLC | 2005 | — |
| −3 | K050704 | Modification to: Revolution XR/D Digital Radiographic Imaging System with… | General Electric Co. | 2005 | 2 |
| −2 | K143270 | Optima XR646 | Ge Hualun Medical Systems Co., Ltd. | 2015 | — |
| −1 | K172869 | Discovery XR656 HD | Ge Hualun Medical Systems Co., Ltd. | 2017 | 1 |
| 0 (this device) | K191699 | Discovery XR656 HD with VolumeRad | Ge Hualun Medical Systems Co., Ltd. | 2019 | — |
| +1 | K250788 | Definium Tempo Select | Ge Hualun Medical Systems Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K132261 | Discovery XR656 with Volumerad (Digital Tomosynthesis)Summary page 4…0 Product Code: Classification: Class II Product Codes: KPR, MQB, IZF Predicate Device Discovery XR656 With VolumeRad (Digital Tomosynthesis) (K132261) #1: Regulation Name: Stationary X-Ray System Regulation: 21 CFR 892.1680 Cl… | 2013 |
| * | K172869 | Discovery XR656 HDSummary page 4…Regulation: 21 CFR 892.1680 Classification: Class II Product Codes: KPR, MQB, IZF Predicate Device Discovery XR656 HD (K172869) #2: Regulation Name: Stationary X-Ray System Regulation: 21 CFR 892.1680 Cl… | 2017 |
| † | K173602 | Optima XR240amx, AutoGrid | 2018 |
| † | K181526 | XRpad2 4343 HWC-M Flat Panel Detector | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250788 | Definium Tempo Select | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 28, 2025 | Class II | Z-1044-2025 | Radiation Control for Health and Safety Act | 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, a message still appears on the… |
| Nov 7, 2023 | Class II | Z-0552-2024 | Process design | 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 elements of the Overhead Tube Suspension… |
| Nov 7, 2023 | Class II | Z-0553-2024 | Process design | 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 elements of the Overhead Tube Suspension… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 7 of the 12 ancestors have a recall of any class.
- Of its descendants, K250788 (Ge Hualun Medical Systems Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K132261.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
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…
Read the full statement (217 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191699 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191699: Discovery XR656 HD with VolumeRad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191699
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026