510(k) · Cleared
ClearedAdvantage Windows Diagnostic X-Ray Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · IZI System, X-Ray, Angiographic
Cleared on Jul 18, 1994 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 1,038 devices in its family, counting itself, has a Class I recall. 1,037 later devices descend from it.
- Decided
- Jul 18, 1994
- Review
- 76 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 0
1,037 later devices descend from it, 4 citing it directly. 1 of the 1,038 devices in this family, counting this one, has a Class I recall.
- This deviceK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- Descendant · cites it directly · 914 of its ownK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- Descendant · 2 generations on · 872 of its ownK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- Descendant · 3 generations on · 637 of its ownK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- Descendant · 4 generations on · 324 of its ownK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
- Descendant · 5 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
Showing 5 of 1,037 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…11 generations on · 2025
Most influential descendants
Showing 5 of 1,037 · See all- K960613GE Advantage Windows Review WorkstationGE Medical Systems · 1996 · cites it directly914descendants
- K020483Advantage Workstation 4.1GE Medical Systems · 2002 · 2 generations on872descendants
- K033400Seno AdvantageGe Medical Systems W-400 · 2003 · 3 generations on637descendants
- K043415Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · 4 generations on324descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 5 generations on287descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| +1 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| +2 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| +3 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| +4 | K043415 | Centricity Pacs System | Ge Medical Systems Information Technologies | 2005 | 23 |
| +5 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 8 | 0 |
| 2004 | 12 | 0 |
| 2005 | 17 | 0 |
| 2006 | 16 | 0 |
| 2007 | 19 | 0 |
| 2008 | 25 | 0 |
| 2009 | 21 | 0 |
| 2010 | 17 | 0 |
| 2011 | 26 | 0 |
| 2012 | 30 | 0 |
| 2013 | 27 | 0 |
| 2014 | 36 | 0 |
| 2015 | 45 | 0 |
| 2016 | 43 | 0 |
| 2017 | 49 | 0 |
| 2018 | 65 | 0 |
| 2019 | 48 | 0 |
| 2020 | 60 | 0 |
| 2021 | 69 | 0 |
| 2022 | 67 | 0 |
| 2023 | 65 | 0 |
| 2024 | 83 | 0 |
| 2025 | 98 | 1 |
| 2026 | 78 | 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.
1 device in this family has a Class I recall. 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 IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (1,037)
See all 1,0374 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 11 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K960613 (GE Medical Systems, 1996) has gone furthest, with 914 descendants of its own.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
MAUDE reports naming product code IZI, 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 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K942120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942120: Advantage Windows Diagnostic X-Ray Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942120
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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