510(k) · Cleared
Recalled · Class II · 2016Advantx LCN, Advantx LCLP
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 Feb 13, 1998 after an 85-day review. The FDA summary names no predicate by number. 1 of the 356 devices in its family, counting itself, has a Class I recall. 355 later devices descend from it. It has been recalled 7 times.
- Decided
- Feb 13, 1998
- Review
- 85 days
- Class
- Class II
- Product code
- IZI
- Recalls
- 7
- Predicates
- 0
355 later devices descend from it, 2 citing it directly. 1 of the 356 devices in this family, counting this one, has a Class I recall.
- This deviceK974367 Advantx LCN, Advantx LCLPGE Medical Systems · 1998
- Descendant · cites it directly · 328 of its ownK983877 Philips Integris 3D RA OptionPhilips Medical Systems North America, Inc. · 1998
- Descendant · 2 generations on · 244 of its ownK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- Descendant · 3 generations on · 218 of its ownK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- Descendant · 4 generations on · 210 of its ownK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- Descendant · 4 generations on · 172 of its ownK062673 Modification to Syngo Inspace 4DSiemens AG Medical Solutions · 2006
Showing 5 of 355 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025
Most influential descendants
Showing 5 of 355 · See all- K983877Philips Integris 3D RA OptionPhilips Medical Systems North America, Inc. · 1998 · cites it directly328descendants
- K011447IN Space 3DSiemens Medical Solutions USA, Inc. · 2001 · 2 generations on244descendants
- K043469Syngo Inspace 4DSiemens AG Medical Solutions · 2005 · 3 generations on218descendants
- K071513Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007 · 4 generations on210descendants
- K062673Modification to Syngo Inspace 4DSiemens AG Medical Solutions · 2006 · 4 generations on172descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974367 | Advantx LCN, Advantx LCLP | GE Medical Systems | 1998 | — |
| +1 | K983877 | Philips Integris 3D RA Option | Philips Medical Systems North America, Inc. | 1998 | — |
| +2 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| +3 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| +4 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| +4 | K062673 | Modification to Syngo Inspace 4D | Siemens AG Medical Solutions | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 6 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 6 | 0 |
| 2011 | 11 | 0 |
| 2012 | 17 | 0 |
| 2013 | 9 | 0 |
| 2014 | 16 | 0 |
| 2015 | 19 | 0 |
| 2016 | 13 | 0 |
| 2017 | 16 | 0 |
| 2018 | 21 | 0 |
| 2019 | 14 | 0 |
| 2020 | 28 | 0 |
| 2021 | 16 | 0 |
| 2022 | 28 | 0 |
| 2023 | 26 | 0 |
| 2024 | 28 | 0 |
| 2025 | 39 | 1 |
| 2026 | 28 | 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.
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?
The FDA summary names no predicate by number.
What descends from it? (355)
See all 3552 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 21, 2016 | Class II | Z-0906-2017 | Nonconforming Material/Component | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems. |
| Nov 21, 2016 | Class II | Z-0907-2017 | Nonconforming Material/Component | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and Innova 2000 systems. |
| Dec 18, 2015 | Class II | Z-0763-2016 | Nonconforming Material/Component | GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor. |
| Aug 16, 2013 | Class II | Z-0021-2014 | Process control | GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular… |
| Dec 22, 2009 | Not classified | Z-0616-2010 | Device Design | Potential table rotation of Omega IV and Omega V tables affecting Advantx-E and Innova 2000, 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ and 3131IQ cardiovascular X-ray imaging systems. Due to potential weakness of some table rotational… |
| Jun 24, 2008 | Not classified | Z-2359-2008 | Employee error | GE Healthcare has become aware of 2 potential conditions that could occur with the MAVIG GD Monitor Suspension that is used with Advantx-E, Innova 2000, 21000IQ, 3100/3100IQ, 4100/4100IQ and 2121 IQ/3131IQ cardiovascular systems. The two… |
| Jan 14, 2008 | Not classified | Z-2038-2008 | Process control | Risk of sudden table drop on Omega IV and Omega V tables on GE Healthcare Advantx-E as well as on Innova 2000, 2100IQ, 3100/3100 IQ and 4100/4100IQ cardiovascular X-ray system |
The 5 latest of 7 recalls; the web page lists all.
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 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K983877 (Philips Medical Systems North America, Inc., 1998) has gone furthest, with 328 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 | — |
What is it indicated for?
The Advantx LCN+ is a biplane x-ray system consisting of a floor mounted three-axis C-arm and a ceiling suspended C-arm that addresses all angiographic procedures that require a 32 cm Image Intensifier.
The Advantx LCLP+ is a biplane x-ray system consisting of a floor mounted three-axis C-arm and a ceiling suspended C-arm that addresses all angiographic procedures that require a 22 cm Image Intensifier.
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/K974367 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974367: Advantx LCN, Advantx LCLP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974367
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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