510(k) · Cleared
ClearedRevolution TX/I Digital Radiographic Table System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · KPR System, X-Ray, Stationary
Cleared on Aug 30, 1999 as substantially equivalent to K982196 (GE Medical Systems, 1998) and 1 other predicate after a 73-day review. Its family tree reaches back 2 generations to 1986. 104 later devices descend from it.
- Decided
- Aug 30, 1999
- Review
- 73 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K862120 (1986). 3 ancestors in all. 104 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 1 generation backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- This deviceK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- Descendant · cites it directly · 103 of its ownK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 48 of its ownK123098 Xgeo GC80Samsung Electronics Co., Ltd. · 2013
- Descendant · 2 generations on · 45 of its ownK013481 Dual Energy and Tissue Equalization Software OptionGE Medical Systems · 2001
- Descendant · 3 generations on · 40 of its ownK140334 Xgeo GC80Samsung Electronics Co., Ltd. · 2014
- Descendant · 4 generations on · 36 of its ownK150165 GC85ASamsung Electronics Co., Ltd. · 2015
Showing 5 of 104 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 104 · See all- K012389Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · cites it directly103descendants
- K123098Xgeo GC80Samsung Electronics Co., Ltd. · 2013 · 2 generations on48descendants
- K013481Dual Energy and Tissue Equalization Software OptionGE Medical Systems · 2001 · 2 generations on45descendants
- K140334Xgeo GC80Samsung Electronics Co., Ltd. · 2014 · 3 generations on40descendants
- K150165GC85ASamsung Electronics Co., Ltd. · 2015 · 4 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −1 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| 0 (this device) | 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 |
| +2 | K123098 | Xgeo GC80 | Samsung Electronics Co., Ltd. | 2013 | — |
| +2 | K013481 | Dual Energy and Tissue Equalization Software Option | GE Medical Systems | 2001 | — |
| +3 | K140334 | Xgeo GC80 | Samsung Electronics Co., Ltd. | 2014 | — |
| +4 | K150165 | GC85A | Samsung Electronics Co., Ltd. | 2015 | — |
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 | 2 | 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? (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 |
|---|---|---|---|
| * | K982196 | Digital Radiographic Imaging SystemSummary page 1…cal Systems 3000 N. Grandview Blvd. Waukesha, WI 53118 Marketed Devices: Digital detector (part of Digital Radiographic Imaging System, renamed Revolution XQ/i system) (K982196); SCX (Advantx) radiographic system (K862120); Ultranet-SA Collimator (K894142); Maxiray 100 Radiographic Tube (Pre-amendment); S… | 1998 |
| * | K884930 | Compax Model 40, 400, 400TSummary page 2…iographic Imaging System in 510(k) K982196. The table used in the Digital Radiographic Table System is substantially equivalent to the Compax 40E table cleared in 510(k) K884930. The device has the same detector and acquisition system as the predicate device, and the same intended uses. It will be evaluat… | 1988 |
What descends from it? (104)
See all 1041 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012389 | Revolution XR/D Digital Radiographic Imaging System | 2001 | 103 |
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 13 years and passes through 2 companies; a new generation was cleared every 12.3 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K012389 (Ge Medical Systems, Inc., 2001) has gone furthest, with 103 descendants of its own.
- 3 other devices also cite its predicate K982196.
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 TX/i Digital Radiographic Table System is indicated for use in generating radiographic images of human anatomy. It is intended to 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/K992066 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992066: Revolution TX/I Digital Radiographic Table System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992066
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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