510(k) · Cleared
Recalled · Class II · 2018Modular Angiography System Axiom Artis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Jun 6, 2002 as substantially equivalent to K010721 (Siemens Medical Corp., 2001) and 1 other predicate after a 69-day review. Its family tree reaches back 2 generations to 1989. 4 of the 224 devices in its family, counting itself, have a Class I recall. 218 later devices descend from it. It has been recalled 21 times.
- Decided
- Jun 6, 2002
- Review
- 69 days
- Class
- Class II
- Product code
- JAA
- Recalls
- 21
- Predicates
- 2
Its longest line of descent runs back 2 generations to K890348 (1989). 5 ancestors in all. 218 later devices descend from it, 5 citing it directly. 4 of the 224 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 1 generation backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- This deviceK021021 Modular Angiography System Axiom ArtisSiemens Medical Solutions USA, Inc. · 2002
- Descendant · cites it directly · 78 of its ownK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · cites it directly · 75 of its ownK033244 Digital Fluoroscopic Imaging System, Model Innova 4100 with Tilt…Ge Medical Systems, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 74 of its ownK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- Descendant · cites it directly · 72 of its ownK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 69 of its ownK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
Showing 5 of 218 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 218 · See all- K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · cites it directly78descendants
- K033244Digital Fluoroscopic Imaging System, Model Innova 4100 with Tilt Table OptionGe Medical Systems, Inc. · 2003 · cites it directly75descendants
- K052412Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQGE Healthcare · 2005 · 2 generations on74descendants
- K073290Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · cites it directly72descendants
- K090745Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · 2 generations on69descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −1 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| 0 (this device) | K021021 | Modular Angiography System Axiom Artis | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +1 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| +1 | K033244 | Digital Fluoroscopic Imaging System, Model Innova 4100 with Tilt Table Option | Ge Medical Systems, Inc. | 2003 | 8 |
| +2 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| +1 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| +2 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 8 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 6 | 0 |
| 2013 | 11 | 0 |
| 2014 | 14 | 0 |
| 2015 | 12 | 0 |
| 2016 | 15 | 1 |
| 2017 | 9 | 2 |
| 2018 | 21 | 0 |
| 2019 | 9 | 0 |
| 2020 | 15 | 1 |
| 2021 | 13 | 0 |
| 2022 | 13 | 0 |
| 2023 | 9 | 0 |
| 2024 | 11 | 0 |
| 2025 | 16 | 0 |
| 2026 | 11 | 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.
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 JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010721 | Axiom Artis Modular Angiography SystemSummary page 1…etween Thales, Philips and Siemens. It may be used with the Siemens AXIOM Artis and the Philips Integris Allura. The AXIOM Artis was described in premarket notification K010721 and received FDA clearance on March 30, 2001. The Philips Integris Allura Flat Detector system with the Trixell Pixium 4800 was d… | 2001 |
| * | K993037 | LCV+ Version 2Summary page 1…s described in premarket notification (510(k) number not yet published) and received FDA clearance on March 15, 2002. INNOVA 2000 was described in premarket notification K993037 and received FDA clearance on Fcbruary 14, 2000. Information that substantiates this claim of equivalence is provided throughout… | 2000 |
| * | — | Philips Integris Allura Flat Detector system Named without a submission number |
What descends from it? (218)
See all 2185 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 |
|---|---|---|---|---|
| May 25, 2018 | Class II | Z-2525-2018 | Process control | Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure |
| Jan 5, 2018 | Class II | Z-1150-2018 | Process control | Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or restart the treatment or transfer the patient to… |
| 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… |
| Feb 19, 2016 | Class II | Z-1310-2016 | Other | Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. This leak can occur sporadically in affected systems. |
| Apr 26, 2013 | Class II | Z-2108-2013 | Nonconforming Material/Component | The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used. |
| Sep 9, 2010 | Not classified | Z-0144-2011 | Software design | Sporadic system crash while Perivision is performed. |
| 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. |
| Apr 12, 2010 | Not classified | Z-1732-2010 | Device Design | sporadic malfunctions of the Artis Systems with Motor Controller caused by tolerances on electronic parts that might increase during the lifetime of the system. |
| Mar 4, 2010 | Not classified | Z-1237-2010 | Nonconforming Material/Component | Due to a contact problem at the low voltage power supply of the generator controller, in rare cases where a user has invoked radiation, it may occur that no radiation is released. Under certain circumstances, radiation is possible by… |
| Feb 16, 2010 | Not classified | Z-1312-2010 | Device Design | Communication problems can occur which may result in unavailability of Bypass Fluoro. |
| Oct 26, 2009 | Not classified | Z-0484-2010 | Other | c-arm may tilt |
| May 1, 2009 | Not classified | Z-1440-2009 | 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. |
The 5 latest of 21 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 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K062623 (Siemens Medical Solutions USA, Inc., 2007) has gone furthest, with 78 descendants of its own.
- 1 other device also cites its predicate K010721.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, 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 | 1 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro-angiography, general angiography, operating room angiography, multipurpose angiography and radiographic/fluoroscopic procedures e.g. Gastro-intestinal imaging, Skeletal imaging ctc. AXIOM Arttis can also support the…
Read the full statement (100 words)
AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures.
Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro-angiography, general angiography, operating room angiography, multipurpose angiography and radiographic/fluoroscopic procedures e.g. Gastro-intestinal imaging, Skeletal imaging ctc.
AXIOM Arttis can also support the acquisition of position triggered imaging for spatial data synthesis.
The intended use and indications for use of the Modular Angiography System AXIOM Artis with Flat Panel Detector as described in its labeling have not changed from its predicate device AXIOM Artis with the 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/K021021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021021: Modular Angiography System Axiom Artis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021021
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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