510(k) · Cleared
ClearedFujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical System U.S.A., Inc. · IZF System, X-Ray, Tomographic
Cleared on Nov 20, 2012 as substantially equivalent to K051967 (GE Healthcare, 2005) and 1 other predicate after a 183-day review. Its family tree reaches back 5 generations to 1986. 6 later devices descend from it.
- Decided
- Nov 20, 2012
- Review
- 183 days
- Class
- Class II
- Product code
- IZF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K862120 (1986). 8 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 backK051967 Revolution XR/D Digital Radiographic Imaging System with TomosynthesisGE Healthcare · 2005 · Recalled
- This deviceK121499 Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray…Fujifilm 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 | K051967 | Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis | GE Healthcare | 2005 | 9 |
| 0 (this device) | K121499 | Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray System | 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 |
| 1994 | 1 | 0 |
| 2010 | 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 IZF? 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 IZF device
- #1 K250850 Nanox.ARC Xscore 15.5 · 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? (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 |
|---|---|---|---|
| * | K051967 | Revolution XR/D Digital Radiographic Imaging System with TomosynthesisSummary page 3…o the following legally marketed devices. Legally Marketed Device 1 510(k) # Revolutionar XR/d with Tomnosynthesis K051967E FDR AcSelerate Stationar X-ray Sstemn K093427 The proposed device has the very similar Indications f… | 2005 |
| * | K093427 | FDR Acselerate System, DR-ID 200 Flat Panel DetectorSummary page 2…s throughout the entire volume of the anatomy. Tomosynthesis will be available as an option to the legally marketed FOR AcSelerate Stationary X-ray System (K093427) with some modifications. To support Tomosynthesis application, the new Tomosynthesis software and new system component ca… | 2010 |
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 5 companies; a new generation was cleared every 4.0 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K152244 (Shimadzu Corporation, 2016) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K051967.
How does its category compare?
All IZF devicesIZF System, X-Ray, Tomographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · IZF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZF
Too few IZF 510(k)s in any year since 2007 to give a median.
Recalls per year · IZF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZF
1in 2021
MAUDE reports naming product code IZF, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 24 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 1 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Fujifilm's Tomosynthesis option is intended to acquire tomographic images of human anatomy and to be used with Fujifilm's DR X-ray systems. Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. It is not intended for mammographic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121499 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121499: Fujifilm Tomosynthesis Option for FDR Acselerate Stationary X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121499
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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