510(k) · Cleared
Recalled · Class II · 2014Revolution XR/D Digital Radiographic Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, Inc. · KPR System, X-Ray, Stationary
Cleared on Aug 10, 2001 as substantially equivalent to K992066 (GE Medical Systems, 1999) after a 14-day review. Its family tree reaches back 3 generations to 1986. 103 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 10, 2001
- Review
- 14 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 3 generations to K862120 (1986). 4 ancestors in all. 103 later devices descend from it, 9 citing it directly.
- Root · 3 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 2 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 1 generation backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- This deviceK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001
- Descendant · cites it directly · 48 of its ownK123098 Xgeo GC80Samsung Electronics Co., Ltd. · 2013
- Descendant · cites it directly · 45 of its ownK013481 Dual Energy and Tissue Equalization Software OptionGE Medical Systems · 2001
- Descendant · 2 generations on · 40 of its ownK140334 Xgeo GC80Samsung Electronics Co., Ltd. · 2014
- Descendant · 3 generations on · 36 of its ownK150165 GC85ASamsung Electronics Co., Ltd. · 2015
- Descendant · 2 generations on · 34 of its ownK092363 Softview, Model 2.01Riverain Medical Group · 2010
Showing 5 of 103 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 103 · See all- K123098Xgeo GC80Samsung Electronics Co., Ltd. · 2013 · cites it directly48descendants
- K013481Dual Energy and Tissue Equalization Software OptionGE Medical Systems · 2001 · cites it directly45descendants
- K140334Xgeo GC80Samsung Electronics Co., Ltd. · 2014 · 2 generations on40descendants
- K150165GC85ASamsung Electronics Co., Ltd. · 2015 · 3 generations on36descendants
- K092363Softview, Model 2.01Riverain Medical Group · 2010 · 2 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −2 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −1 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| 0 (this device) | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | — |
| +1 | K123098 | Xgeo GC80 | Samsung Electronics Co., Ltd. | 2013 | — |
| +1 | K013481 | Dual Energy and Tissue Equalization Software Option | GE Medical Systems | 2001 | — |
| +2 | K140334 | Xgeo GC80 | Samsung Electronics Co., Ltd. | 2014 | — |
| +3 | K150165 | GC85A | Samsung Electronics Co., Ltd. | 2015 | — |
| +2 | K092363 | Softview, Model 2.01 | Riverain Medical Group | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 8 | 0 |
| 2016 | 7 | 0 |
| 2017 | 5 | 0 |
| 2018 | 12 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 11 | 0 |
| 2023 | 5 | 0 |
| 2024 | 9 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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? (1)
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 |
|---|---|---|---|
| * | K992066 | Revolution TX/I Digital Radiographic Table SystemSummary page 2…n enhanced version of and substantially equivalent to the 1/2 rev.25 Jun 2001 Revolution XR/D Digital Radiographic Imaging System, originally cleared in K992066. Conformance: The Revolution XR/d Digital Radiographic imaging System. will conform to applicable sections of 21CFR 1020.30, 102… | 1999 |
What descends from it? (103)
See all 1039 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123098 | Xgeo GC80 | 2013 | 48 |
| K013481 | Dual Energy and Tissue Equalization Software Option | 2001 | 45 |
| K051967 | Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis | 2005 | 29 |
| K042602 | Revolution XR/D Digital Radiographic Imaging System with Manual Image Pasting | 2005 | 8 |
| K050704 | Modification to: Revolution XR/D Digital Radiographic Imaging System with Image Pasting… | 2005 | 7 |
| K083640 | Digital X-Ray Imaging System, Model: CXD-DR80D | 2009 | 2 |
| K152813 | FS-500DDR Medical Radiographic X-Ray System | 2016 | 0 |
| K123105 | Xgeo GU60 | 2013 | 0 |
| K121854 | System, X-Ray, Stationary | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 4, 2014 | Class II | Z-1989-2014 | Equipment maintenance | GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident… |
| Aug 13, 2009 | Not classified | Z-0527-2010 | Nonconforming Material/Component | Certain GE Radiographic fixed X-ray tables (Proteus XR/a, Revolution XR/d, and Definium 8000) were found to have tabletops that move unexpectedly in a bi-directional mode. In rare cases, a malfunction may occur, which could result in the… |
| May 31, 2006 | Class II | Z-1789-2012 | Device Design | An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath |
| Nov 21, 2002 | Not classified | Z-0157-03 | Other | The devices do not meet requirements in 21 CFR 1010.2 in that they lack certification labels. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K123098 (Samsung Electronics Co., Ltd., 2013) has gone furthest, with 48 descendants of its own.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Revolution XR/d Digital Radiographic X-ray System is indicated for use in generating radiographic images of human anatomy. It is intended for use in replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012389 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012389: Revolution XR/D Digital Radiographic Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012389
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026