510(k) · Cleared
ClearedDual Energy and Tissue Equalization Software Option
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 Nov 2, 2001 as substantially equivalent to K012389 (Ge Medical Systems, Inc., 2001) after a 14-day review. Its family tree reaches back 4 generations to 1986. 45 later devices descend from it.
- Decided
- Nov 2, 2001
- Review
- 14 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K862120 (1986). 5 ancestors in all. 45 later devices descend from it, 3 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 deviceK013481 Dual Energy and Tissue Equalization Software OptionGE Medical Systems · 2001
- Descendant · cites it directly · 34 of its ownK092363 Softview, Model 2.01Riverain Medical Group · 2010
- Descendant · 2 generations on · 25 of its ownK123526 Clearread +ConfirmRiverain Technologies · 2012
- Descendant · 3 generations on · 23 of its ownK162278 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016
- Descendant · 4 generations on · 22 of its ownK171119 GM85Samsung Electronics Co., Ltd. · 2017 · Recalled
- Descendant · 5 generations on · 19 of its ownK173828 GU60A & GU60A-65Samsung Electronics Co., Ltd. · 2018
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K092363Softview, Model 2.01Riverain Medical Group · 2010 · cites it directly34descendants
- K123526Clearread +ConfirmRiverain Technologies · 2012 · 2 generations on25descendants
- K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016 · 3 generations on23descendants
- K171119GM85Samsung Electronics Co., Ltd. · 2017 · 4 generations on22descendants
- K173828GU60A & GU60A-65Samsung Electronics Co., Ltd. · 2018 · 5 generations on19descendants
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) | K013481 | Dual Energy and Tissue Equalization Software Option | GE Medical Systems | 2001 | — |
| +1 | K092363 | Softview, Model 2.01 | Riverain Medical Group | 2010 | — |
| +2 | K123526 | Clearread +Confirm | Riverain Technologies | 2012 | — |
| +3 | K162278 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | 2016 | — |
| +4 | K171119 | GM85 | Samsung Electronics Co., Ltd. | 2017 | 1 |
| +5 | K173828 | GU60A & GU60A-65 | Samsung Electronics Co., Ltd. | 2018 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 9 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 7 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K012389 | Revolution XR/D Digital Radiographic Imaging SystemSummary page 1…are options are substantially equivalent to the Dual Energy and Tissue Equalization software options for use on the Revolution XR/d Digital Radiographic imaging System (K012389). Dual Energy and Tissue Equalization software options will conform to applicable sections of 21CFR 1020.30 and 1020.31. The sof… | 2001 |
What descends from it? (45)
See all 453 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)
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 15 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K092363 (Riverain Medical Group, 2010) has gone furthest, with 34 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?
Dual Energy and Tissue Equalization software options are intended for use in generating digital 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/K013481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013481: Dual Energy and Tissue Equalization Software Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013481
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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