510(k) · Cleared
Recalled · Class II · 2017Axiom Artis Modular Angiography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Corp. · IZI System, X-Ray, Angiographic
Cleared on Mar 30, 2001 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 249 devices in its family, counting itself, have a Class I recall. 248 later devices descend from it. It has been recalled 26 times.
- Decided
- Mar 30, 2001
- Review
- 18 days
- Class
- Class II
- Product code
- IZI
- Recalls
- 26
- Predicates
- 0
248 later devices descend from it, 2 citing it directly. 4 of the 249 devices in this family, counting this one, have a Class I recall.
- This deviceK010721 Axiom Artis Modular Angiography SystemSiemens Medical Corp. · 2001
- Descendant · cites it directly · 218 of its ownK021021 Modular Angiography System Axiom ArtisSiemens Medical Solutions USA, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 78 of its ownK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 75 of its ownK033244 Digital Fluoroscopic Imaging System, Model Innova 4100 with Tilt…Ge Medical Systems, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 74 of its ownK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- Descendant · 2 generations on · 72 of its ownK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
Showing 5 of 248 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 248 · See all- K021021Modular Angiography System Axiom ArtisSiemens Medical Solutions USA, Inc. · 2002 · cites it directly218descendants
- K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on78descendants
- K033244Digital Fluoroscopic Imaging System, Model Innova 4100 with Tilt Table OptionGe Medical Systems, Inc. · 2003 · 2 generations on75descendants
- K052412Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQGE Healthcare · 2005 · 3 generations on74descendants
- K073290Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · 2 generations on72descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010721 | Axiom Artis Modular Angiography System | Siemens Medical Corp. | 2001 | — |
| +1 | K021021 | Modular Angiography System Axiom Artis | Siemens Medical Solutions USA, Inc. | 2002 | 21 |
| +2 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| +2 | K033244 | Digital Fluoroscopic Imaging System, Model Innova 4100 with Tilt Table Option | Ge Medical Systems, Inc. | 2003 | 8 |
| +3 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| +2 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 8 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 9 | 0 |
| 2012 | 6 | 0 |
| 2013 | 11 | 0 |
| 2014 | 15 | 0 |
| 2015 | 12 | 0 |
| 2016 | 17 | 1 |
| 2017 | 10 | 2 |
| 2018 | 22 | 0 |
| 2019 | 12 | 0 |
| 2020 | 19 | 1 |
| 2021 | 14 | 0 |
| 2022 | 15 | 0 |
| 2023 | 12 | 0 |
| 2024 | 12 | 0 |
| 2025 | 18 | 0 |
| 2026 | 14 | 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.
4 devices in this family have 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? (248)
See all 2482 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 28, 2017 | Class II | Z-0711-2018 | Device Design | The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release… |
| Jul 13, 2016 | Class II | Z-2393-2016 | Under Investigation by firm | The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system. |
| Jun 29, 2015 | Class II | Z-2342-2015 | Device Design | The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported. |
| Jun 5, 2014 | Class II | Z-2587-2014 | Device Design | There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand switch operated at the patient table which may result in uncontrolled release of an x-ray image. |
| Jul 13, 2010 | Not classified | Z-2233-2010 | Other | The Axiom Artis MP, Artis dMP or Artis zee Multipurpose C-arm gearbox can become damaged. If the gearbox is damaged, the C-arm may tilt away when being repositioned and collide with nearby objects in its range of motion. |
| Oct 26, 2009 | Not classified | Z-0483-2010 | Other | c-arm may tilt |
| May 1, 2009 | Not classified | Z-1439-2009 | Other | Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall. |
| Sep 2, 2008 | Not classified | Z-0128-2009 | Software design | Incorrect contour finding: Image may be calibrated to the wrong size catheter. |
| Sep 2, 2008 | Not classified | Z-0121-2009 | Software design | Incorrect contour finding: Image may be calibrated to the wrong size catheter. |
| Sep 2, 2008 | Not classified | Z-0122-2009 | Software design | Incorrect contour finding: Image may be calibrated to the wrong size catheter. |
| Sep 2, 2008 | Not classified | Z-0123-2009 | Software design | Incorrect contour finding: Image may be calibrated to the wrong size catheter. |
| Sep 2, 2008 | Not classified | Z-0125-2009 | Software design | Incorrect contour finding: Image may be calibrated to the wrong size catheter. |
| Sep 2, 2008 | Not classified | Z-0127-2009 | Software design | Incorrect contour finding: Image may be calibrated to the wrong size catheter. |
| Sep 2, 2008 | Not classified | Z-0120-2009 | Software design | Incorrect contour finding: Image may be calibrated to the wrong size catheter. |
| Sep 2, 2008 | Not classified | Z-0124-2009 | Software design | Incorrect contour finding: Image may be calibrated to the wrong size catheter. |
| Sep 2, 2008 | Not classified | Z-0126-2009 | Software design | Incorrect contour finding: Image may be calibrated to the wrong size catheter. |
| Aug 22, 2008 | Not classified | Z-0193-2009 | Labeling design | Patients could possibly fall off the table if not properly secured when: 1) moving them onto the patient table, 2) moving them on the patient table or 3) removing them from the patient table. |
| Jan 31, 2007 | Not classified | Z-0578-2007 | Other | C-arm gantry could rapidly descend without command during use. |
| Jan 31, 2007 | Not classified | Z-0579-2007 | Other | C-arm gantry could rapidly descend without command during use |
| Apr 11, 2005 | Not classified | Z-0796-05 | Other | Live display in exam room may sporadically stop working although the display in the control room remains fully operational |
| Apr 1, 2005 | Not classified | Z-0818-05 | Other | potential problem with the fluoroscopy switch on the power grip |
| Aug 10, 2004 | Not classified | Z-1449-04 | Other | Opacification Function of device may incorrectly merge images |
| Aug 10, 2004 | Not classified | Z-1450-04 | Other | Opacification Function of device may incorrectly merge images |
| Jun 2, 2004 | Not classified | Z-1108-04 | Other | Error appears in the AUTOMAP function, Module 2, when PERISTEEPING or PERIVISION is activated simultaneously that causes system to crash. |
| May 28, 2003 | Not classified | Z-0848-04 | Other | patient images misidentified |
| Aug 5, 2002 | Not classified | Z-0347-03 | Other | Set delay time for contrast injection exceeds 10 seconds, radiation release button is blocked. |
The 5 latest of 26 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.
- K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 8 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- Of its descendants, K021021 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 218 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/K010721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010721: Axiom Artis Modular Angiography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010721
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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