510(k) · Cleared
ClearedRevolution XR/D Digital Radiographic Imaging System with Manual Image Pasting
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jan 13, 2005 as substantially equivalent to K012389 (Ge Medical Systems, Inc., 2001) after a 111-day review. Its family tree reaches back 4 generations to 1986. 8 later devices descend from it.
- Decided
- Jan 13, 2005
- Review
- 111 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K862120 (1986). 5 ancestors in all. 8 later devices descend from it, 1 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 deviceK042602 Revolution XR/D Digital Radiographic Imaging System with Manual…Ge Medical Systems, LLC · 2005
- Descendant · cites it directly · 7 of its ownK050704 Modification to: Revolution XR/D Digital Radiographic Imaging System…General Electric Co. · 2005 · Recalled
- Descendant · 2 generations on · 6 of its ownK143270 Optima XR646Ge Hualun Medical Systems Co., Ltd. · 2015
- Descendant · 3 generations on · 5 of its ownK172869 Discovery XR656 HDGe Hualun Medical Systems Co., Ltd. · 2017 · Recalled
- Descendant · 4 generations on · 1 of its ownK231892 Definium Pace SelectGe Hualun Medical Systems Co., Ltd. · 2023 · Recalled
- Descendant · 4 generations on · 1 of its ownK191699 Discovery XR656 HD with VolumeRadGe Hualun Medical Systems Co., Ltd. · 2019 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K050704Modification to: Revolution XR/D Digital Radiographic Imaging System with Image Pasting…General Electric Co. · 2005 · cites it directly7descendants
- K143270Optima XR646Ge Hualun Medical Systems Co., Ltd. · 2015 · 2 generations on6descendants
- K172869Discovery XR656 HDGe Hualun Medical Systems Co., Ltd. · 2017 · 3 generations on5descendants
- K231892Definium Pace SelectGe Hualun Medical Systems Co., Ltd. · 2023 · 4 generations on1descendant
- K191699Discovery XR656 HD with VolumeRadGe Hualun Medical Systems Co., Ltd. · 2019 · 4 generations on1descendant
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) | K042602 | Revolution XR/D Digital Radiographic Imaging System with Manual Image Pasting | Ge Medical Systems, LLC | 2005 | — |
| +1 | 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 | — |
| +3 | K172869 | Discovery XR656 HD | Ge Hualun Medical Systems Co., Ltd. | 2017 | 1 |
| +4 | K231892 | Definium Pace Select | Ge Hualun Medical Systems Co., Ltd. | 2023 | 1 |
| +4 | K191699 | Discovery XR656 HD with VolumeRad | Ge Hualun Medical Systems Co., Ltd. | 2019 | 3 |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 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 |
|---|---|---|---|
| * | K012389 | Revolution XR/D Digital Radiographic Imaging SystemSummary page 1…d Digital Radiographic Imaging System 21 CFR 892.1680 and 892.1650; 80 KPR and 80 MQB Marketed Device: Revolution XR/d Digtal Radiographic Imaging System, 510(k) Number K012389, currently in commercial distribution. Device Description: Image pasting allows the operator to generate 2 to 5 sequential radio… | 2001 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050704 | Modification to: Revolution XR/D Digital Radiographic Imaging System with Image Pasting… | 2005 | 7 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
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 3.4 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K050704 (General Electric Co., 2005) has gone furthest, with 7 descendants of its own.
- 8 other devices also cite its predicate K012389.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
Image Pasting Application for Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. 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/K042602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042602: Revolution XR/D Digital Radiographic Imaging System with Manual Image Pasting.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042602
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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