510(k) · Cleared
Recalled · Class II · 2021Axiom Artis - Modular Angiographic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Mar 7, 2006 as substantially equivalent to K994231 (Siemens Medical Corp., 2000) and 1 other predicate after a 207-day review. Its family tree reaches back 5 generations to 1980. 4 of the 188 devices in its family, counting itself, have a Class I recall. 154 later devices descend from it. It has been recalled 29 times.
- Decided
- Mar 7, 2006
- Review
- 207 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 29
- Predicates
- 3
Its longest line of descent runs back 5 generations to K801623 (1980). 33 ancestors in all. 154 later devices descend from it, 2 citing it directly. 4 of the 188 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 4 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 3 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 2 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 1 generation backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- This deviceK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006
- Descendant · cites it directly · 80 of its ownK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 78 of its ownK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · 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
- Descendant · 2 generations on · 43 of its ownK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
Showing 5 of 154 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 154 · See all- K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · cites it directly80descendants
- K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on78descendants
- 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
- K081722YSIOSiemens Medical Solutions USA, Inc. · 2008 · 2 generations on43descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −4 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −3 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −2 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −1 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| 0 (this device) | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +1 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| +2 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| +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 |
| +2 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 9 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 10 | 0 |
| 2014 | 11 | 0 |
| 2015 | 7 | 0 |
| 2016 | 11 | 1 |
| 2017 | 6 | 2 |
| 2018 | 11 | 0 |
| 2019 | 7 | 0 |
| 2020 | 12 | 1 |
| 2021 | 9 | 0 |
| 2022 | 10 | 0 |
| 2023 | 7 | 0 |
| 2024 | 7 | 0 |
| 2025 | 13 | 0 |
| 2026 | 9 | 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
What descends from it? (154)
See all 1542 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 |
|---|---|---|---|---|
| Mar 30, 2021 | Class II | Z-1496-2021 | Equipment maintenance | Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts which are needed to move system parts (e.g. C-Arm), Increased corrosion may lead to a malfunction of the belts which may result in limited… |
| Jun 12, 2019 | Class II | Z-2018-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2019-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2016-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2023-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2027-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2015-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2025-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2013-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2024-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2012-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2017-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2014-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2026-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2020-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2021-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| Jun 12, 2019 | Class II | Z-2022-2019 | Component design/selection | A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue… |
| 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… |
| Jun 6, 2017 | Class II | Z-0708-2018 | Device Design | Potential for liquid entry |
| Feb 27, 2017 | Class II | Z-1468-2017 | Process control | A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in… |
| Nov 1, 2016 | Class II | Z-0603-2017 | Software in the Use Environment | The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times. |
| Jan 16, 2012 | Not classified | Z-0927-2012 | Software change control | There is a potential misalignment in the connection of the remote foot switch and the stationary unit. This potential malfunction may occur if either the wireless foot switch or the stationary unit is equipped with improper firmware… |
| May 1, 2009 | Not classified | Z-1441-2009 | Other | Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall. |
| Aug 25, 2008 | Not classified | Z-0316-2009 | Software design | System may switch to emergency fluoroscopy mode. |
| Aug 25, 2008 | Not classified | Z-0313-2009 | Software design | System may switch to emergency fluoroscopy mode. |
| Aug 25, 2008 | Not classified | Z-0315-2009 | Software design | System may switch to emergency fluoroscopy mode. |
| Aug 25, 2008 | Not classified | Z-0312-2009 | Software design | System may switch to emergency fluoroscopy mode. |
| Aug 25, 2008 | Not classified | Z-0314-2009 | Software design | System may switch to emergency fluoroscopy mode. |
| Aug 25, 2008 | Not classified | Z-0317-2009 | Software design | System may switch to emergency fluoroscopy mode. |
The 5 latest of 29 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?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 33 ancestors has a recall of any class.
- Of its descendants, K061054 (Siemens Medical Solutions USA, Inc., 2006) has gone furthest, with 80 descendants of its own.
- 1 other device also cites its predicate K994231.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
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 etc. AXIOM Artis 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 etc.
AXIOM Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
The intended use and indications for use of the AXIOM Artis with wireless footswitch and with voice control as described in its labeling have not changed from its predicate device the AXIOM Artis Modular Angiographic System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052202 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052202: Axiom Artis - Modular Angiographic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052202
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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