510(k) · Cleared
Recalled · 2009Compax Model 40, 400, 400T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · IZZ Table, Radiographic, Non-Tilting, Powered
Cleared on Dec 22, 1988 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 293 later devices descend from it. It has been recalled once.
- Decided
- Dec 22, 1988
- Review
- 27 days
- Class
- Class II
- Product code
- IZZ
- Recalls
- 1
- Predicates
- 0
293 later devices descend from it, 2 citing it directly.
- This deviceK884930 Compax Model 40, 400, 400TGeneral Electric Co. · 1988
- Descendant · cites it directly · 197 of its ownK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- Descendant · 2 generations on · 187 of its ownK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- Descendant · cites it directly · 104 of its ownK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- Descendant · 2 generations on · 103 of its ownK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- Descendant · 3 generations on · 103 of its ownK992794 Stingray DR, Model 1Infimed, Inc. · 1999
Showing 5 of 293 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 293 · See all- K971452Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · cites it directly197descendants
- K983732Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · 2 generations on187descendants
- K992066Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999 · cites it directly104descendants
- K012389Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · 2 generations on103descendants
- K992794Stingray DR, Model 1Infimed, Inc. · 1999 · 3 generations on103descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K884930 | Compax Model 40, 400, 400T | General Electric Co. | 1988 | — |
| +1 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| +2 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| +1 | 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 |
| +3 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 10 | 0 |
| 2011 | 11 | 0 |
| 2012 | 12 | 0 |
| 2013 | 14 | 0 |
| 2014 | 17 | 0 |
| 2015 | 20 | 0 |
| 2016 | 20 | 0 |
| 2017 | 15 | 0 |
| 2018 | 20 | 0 |
| 2019 | 20 | 0 |
| 2020 | 17 | 0 |
| 2021 | 16 | 0 |
| 2022 | 20 | 0 |
| 2023 | 11 | 0 |
| 2024 | 14 | 0 |
| 2025 | 14 | 0 |
| 2026 | 11 | 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 IZZ? 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? (293)
See all 2932 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 |
|---|---|---|---|---|
| Jul 30, 2009 | Not classified | Z-0457-2010 | Other | GE Healthcare has recently become aware that table lock safety features, which are provided with Compax 40E X-ray systems, are not always being utilized and has resulted in unintended lateral tabletop movement that may impact patient… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K971452 (Siemens Medical Solutions USA, Inc., 1997) has gone furthest, with 197 descendants of its own.
How does its category compare?
All IZZ devicesIZZ Table, Radiographic, Non-Tilting, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZZ
FDA has decided no IZZ device since 2007.
Median 510(k) review, days · IZZ
Too few IZZ 510(k)s in any year since 2007 to give a median.
Recalls per year · IZZ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZZ
2in 2025
MAUDE reports naming product code IZZ, 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 | 35 |
| 2009 | 0 | — | 1 | 20 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K884930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K884930: Compax Model 40, 400, 400T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884930
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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