510(k) · Cleared
Recalled · Class II · 2016Fuji Computed Radiography Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical System U.S.A., Inc. · IXW Processor, Radiographic-Film, Automatic
Cleared on May 11, 1995 after a 266-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 84 later devices descend from it. It has been recalled once.
- Decided
- May 11, 1995
- Review
- 266 days
- Class
- Class II
- Product code
- IXW
- Recalls
- 1
- Predicates
- 0
84 later devices descend from it, 2 citing it directly.
- This deviceK944046 Fuji Computed Radiography SystemsFujifilm Medical System U.S.A., Inc. · 1995
- Descendant · cites it directly · 82 of its ownK993861 Fuji Computed Radiography Dual Side Reading, Both Side Reading, FCR…Fujifilm Medical System U.S.A., Inc. · 2000 · Recalled
- Descendant · 2 generations on · 78 of its ownK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- Descendant · 3 generations on · 34 of its ownK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- Descendant · 3 generations on · 30 of its ownK120020 Vivix-SVieworks Co., Ltd. · 2012
- Descendant · 4 generations on · 28 of its ownK122865 Vivix-S WirelessVieworks Co., Ltd. · 2013
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K993861Fuji Computed Radiography Dual Side Reading, Both Side Reading, FCR 5501D Dual Side ReaderFujifilm Medical System U.S.A., Inc. · 2000 · cites it directly82descendants
- K024147Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003 · 2 generations on78descendants
- K092669DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · 3 generations on34descendants
- K120020Vivix-SVieworks Co., Ltd. · 2012 · 3 generations on30descendants
- K122865Vivix-S WirelessVieworks Co., Ltd. · 2013 · 4 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944046 | Fuji Computed Radiography Systems | Fujifilm Medical System U.S.A., Inc. | 1995 | — |
| +1 | K993861 | Fuji Computed Radiography Dual Side Reading, Both Side Reading, FCR 5501D Dual… | Fujifilm Medical System U.S.A., Inc. | 2000 | 1 |
| +2 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| +3 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| +3 | K120020 | Vivix-S | Vieworks Co., Ltd. | 2012 | — |
| +4 | K122865 | Vivix-S Wireless | Vieworks Co., Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 9 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IXW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (84)
See all 842 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2016 | Class II | Z-1599-2016 | Device Design | Reports of failure of the device's power supply. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K993861 (Fujifilm Medical System U.S.A., Inc., 2000) has gone furthest, with 82 descendants of its own.
How does its category compare?
All IXW devicesIXW Processor, Radiographic-Film, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXW
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · IXW
Too few IXW 510(k)s in any year since 2007 to give a median.
Recalls per year · IXW
No recall names IXW since 2007.
Adverse event reports per year · IXW
2in 2018
MAUDE reports naming product code IXW, 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 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K944046 · printed Nov 5, 2026
Cite this page
510(k) Report. “K944046: Fuji Computed Radiography Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944046
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026