510(k) · Cleared
Recalled · Class II · 2011Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · KPR System, X-Ray, Stationary
Cleared on Aug 9, 2005 as substantially equivalent to K012389 (Ge Medical Systems, Inc., 2001) and 1 other predicate after a 20-day review. Its family tree reaches back 4 generations to 1986. 29 later devices descend from it. It has been recalled 9 times.
- Decided
- Aug 9, 2005
- Review
- 20 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 9
- Predicates
- 2
Its longest line of descent runs back 4 generations to K862120 (1986). 6 ancestors in all. 29 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 3 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 2 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 1 generation backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- This deviceK051967 Revolution XR/D Digital Radiographic Imaging System with TomosynthesisGE Healthcare · 2005
- Descendant · cites it directly · 21 of its ownK132261 Discovery XR656 with Volumerad (Digital Tomosynthesis)Ge Medical Systems, LLC · 2013 · Recalled
- Descendant · 2 generations on · 8 of its ownK183275 DR 800 with TomosynthesisAgfa N.V. · 2019 · Recalled
- Descendant · 2 generations on · 6 of its ownK143270 Optima XR646Ge Hualun Medical Systems Co., Ltd. · 2015
- Descendant · cites it directly · 6 of its ownK121499 Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray…Fujifilm Medical System U.S.A., Inc. · 2012
- Descendant · 3 generations on · 5 of its ownK172869 Discovery XR656 HDGe Hualun Medical Systems Co., Ltd. · 2017 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K132261Discovery XR656 with Volumerad (Digital Tomosynthesis)Ge Medical Systems, LLC · 2013 · cites it directly21descendants
- K183275DR 800 with TomosynthesisAgfa N.V. · 2019 · 2 generations on8descendants
- K143270Optima XR646Ge Hualun Medical Systems Co., Ltd. · 2015 · 2 generations on6descendants
- K121499Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray SystemFujifilm Medical System U.S.A., Inc. · 2012 · cites it directly6descendants
- K172869Discovery XR656 HDGe Hualun Medical Systems Co., Ltd. · 2017 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −3 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −2 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −1 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| 0 (this device) | K051967 | Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis | GE Healthcare | 2005 | — |
| +1 | K132261 | Discovery XR656 with Volumerad (Digital Tomosynthesis) | Ge Medical Systems, LLC | 2013 | 1 |
| +2 | K183275 | DR 800 with Tomosynthesis | Agfa N.V. | 2019 | 3 |
| +2 | K143270 | Optima XR646 | Ge Hualun Medical Systems Co., Ltd. | 2015 | — |
| +1 | K121499 | Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray System | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| +3 | K172869 | Discovery XR656 HD | Ge Hualun Medical Systems Co., Ltd. | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K012389 | Revolution XR/D Digital Radiographic Imaging SystemSummary page 1…Revolution XRPd Digital Radiographic Imaging System with Tomosynthesis System, 510(k) Number K012389, Marketed Device: Revolution XR/d Digital Radiographic Imaging distribution. Tomo-Link, K944967, currently… | 2001 |
| * | K944967 | Tomo-LinkSummary page 1…System, 510(k) Number K012389, Marketed Device: Revolution XR/d Digital Radiographic Imaging distribution. Tomo-Link, K944967, currently in commercial to perform radiograph… | 1994 |
What descends from it? (29)
See all 292 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 26, 2011 | Not classified | Z-1065-2012 | Device Design | GE Healthcare has become aware of a potential issue associated with the hand grip that is clamped to the table top of your Revolution XRD X-ray systems that may impact patient safety. The hand grip accessory that is clamped to the table… |
| Aug 13, 2009 | Not classified | Z-0528-2010 | 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… |
| Mar 7, 2008 | Not classified | Z-1822-2008 | Software design | Loss of image data: Software anomaly in the Processing Software on the Definium 8000 system may impact patient safety when using the VolumeRAD advanced application (option). The slice visualization of VolumeRAD exams acquired on the… |
| Mar 7, 2008 | Not classified | Z-1882-2008 | Software design | Radiation dose reading greater than actual dose: Error in the generator software on the GE Healthcare Revolution XR/d configured with HP 8200 PC consoles and all Definium 8000 systems may impact patient safety. Occasional generator… |
| Feb 14, 2008 | Not classified | Z-0002-2009 | Software design | GE Healthcare has recently become aware of a potential risk of observing a blank image after exposure on Revolution XR/d systems equipped with HP 8200 PC user consoles that may impact patient safety. It was reported that images acquired… |
| Feb 14, 2008 | Not classified | Z-0003-2009 | Software design | GE Healthcare has recently become aware of an error in the generator software on the Revolution XR/d configured with HP 8200 PC consoles that reports a mAs reading that is higher than is actually exposed to patients. |
| Jan 2, 2008 | Not classified | Z-1883-2008 | Radiation Control for Health and Safety Act | Not properly labeling the manual switch for disabling positive beam limitation (PBL) located on the overhead tube support user interface as required |
| Aug 13, 2007 | Not classified | Z-1476-2008 | Radiation Control for Health and Safety Act | Necessary certification labels are missing from the x-ray contol. |
| May 31, 2006 | Class II | Z-1788-2012 | 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 |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K132261 (Ge Medical Systems, LLC, 2013) has gone furthest, with 21 descendants of its own.
- 8 other devices also cite its predicate K012389.
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?
Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating Tomographic images of human anatomy. This device is not intended for mammographic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051967 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051967: Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051967
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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