510(k) · Cleared
ClearedFujifilm Dual Energy Subtraction (Des) Software Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical System U.S.A., Inc. · KPR System, X-Ray, Stationary
Cleared on Nov 20, 2012 as substantially equivalent to K952862 (Fujifilm Medical System U.S.A., Inc., 1995) and 1 other predicate after a 99-day review. Its family tree reaches back 5 generations to 1986. 6 later devices descend from it.
- Decided
- Nov 20, 2012
- Review
- 99 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K862120 (1986). 7 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 4 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 3 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 2 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 1 generation backK013481 Dual Energy and Tissue Equalization Software OptionGE Medical Systems · 2001
- This deviceK122454 Fujifilm Dual Energy Subtraction (Des) Software OptionFujifilm Medical System U.S.A., Inc. · 2012
- Descendant · cites it directly · 3 of its ownK152244 RADspeed ProShimadzu Corporation · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK173517 RADspeed fitShimadzu Corporation · 2018
- Descendant · cites it directly · 1 of its ownK152294 FDR Visionary SuiteShimadzu Corporation · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK233719 FDR Visionary SuiteShimadzu Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK233722 RADspeed ProShimadzu Corporation · 2024 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K152244RADspeed ProShimadzu Corporation · 2016 · cites it directly3descendants
- K173517RADspeed fitShimadzu Corporation · 2018 · 2 generations on1descendant
- K152294FDR Visionary SuiteShimadzu Corporation · 2016 · cites it directly1descendant
- K233719FDR Visionary SuiteShimadzu Corporation · 2024 · 2 generations on0descendants
- K233722RADspeed ProShimadzu Corporation · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −4 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −3 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −2 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −1 | K013481 | Dual Energy and Tissue Equalization Software Option | GE Medical Systems | 2001 | — |
| 0 (this device) | K122454 | Fujifilm Dual Energy Subtraction (Des) Software Option | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| +1 | K152244 | RADspeed Pro | Shimadzu Corporation | 2016 | 2 |
| +2 | K173517 | RADspeed fit | Shimadzu Corporation | 2018 | — |
| +1 | K152294 | FDR Visionary Suite | Shimadzu Corporation | 2016 | 5 |
| +2 | K233719 | FDR Visionary Suite | Shimadzu Corporation | 2024 | — |
| +2 | K233722 | RADspeed Pro | Shimadzu Corporation | 2024 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K952862 | Fuji Computed Radiography System FCR9501ES.FCRSummary page 3…M Fujifilm Medical Systems, USA IV. SUBSTANTIAL EQUIVALENCE Fujifilm's FDR Dual Energy Subtraction (DES) Option is a modification to our currently- cleared FCR 9501ES (K952862) and is also substantially equivalent to General Electric’s Dual Energy and Tissue Equalization Software Options for Digital Radi… | 1995 |
| * | K013481 | Dual Energy and Tissue Equalization Software OptionSummary page 3…ed FCR 9501ES (K952862) and is also substantially equivalent to General Electric’s Dual Energy and Tissue Equalization Software Options for Digital Radiographic Systems (K013481). A detailed Substantial Equivalence Comparison is provided in Section 12. V. CONCLUSION : The proposed optional FDR Dual Ener… | 2001 |
What descends from it? (6)
2 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 26 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K152244 (Shimadzu Corporation, 2016) has gone furthest, with 3 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. 2012, this device’s year, is highlighted.
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?
Fujifilm’s FDR Dual Energy Subtraction (DES) Option may be used with Fuijifilm's DR X-ray Systems and is intended to be used by a qualified/trained doctor or technologist for acquiring dual energy subtraction images of human anatomy.
DES is intended to assist the physician through the visualization of anomalies by reducing the visibility of underlying / overlying anatomical structures.
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/K122454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122454: Fujifilm Dual Energy Subtraction (Des) 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/K122454
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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