510(k) · Cleared
Recalled · Class II · 2019Artis Zee and Zeego
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IZI System, X-Ray, Angiographic
Cleared on Feb 11, 2008 as substantially equivalent to K021021 (Siemens Medical Solutions USA, Inc., 2002) and 1 other predicate after an 82-day review. Its family tree reaches back 6 generations to 1980. 4 of the 113 devices in its family, counting itself, have a Class I recall. 72 later devices descend from it. It has been recalled 39 times.
- Decided
- Feb 11, 2008
- Review
- 82 days
- Class
- Class II
- Product code
- IZI
- Recalls
- 39
- Predicates
- 2
Its longest line of descent runs back 6 generations to K801623 (1980). 40 ancestors in all. 72 later devices descend from it, 3 citing it directly. 4 of the 113 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 5 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 4 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 3 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 2 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 1 generation backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- This deviceK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008
- Descendant · cites it directly · 69 of its ownK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 33 of its ownK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 30 of its ownK122644 Artis Zee/Zeego with CSX-10 Detector SW VC21Siemens Medical Solutions USA, Inc. · 2013 · Recalled
- Descendant · cites it directly · 24 of its ownK102005 Allura Xper or Table SeriesPhilips Medical Systems North America, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 23 of its ownK163286 ARTIS phenoSiemens Medical Solution USA, Inc. · 2017 · Recalled
Showing 5 of 72 descendants. See all descendants
Descendants cleared per year
2009high 8 (2025) · low 1 (2010)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 72 · See all- K090745Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · cites it directly69descendants
- K123529Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · 2 generations on33descendants
- K122644Artis Zee/Zeego with CSX-10 Detector SW VC21Siemens Medical Solutions USA, Inc. · 2013 · 2 generations on30descendants
- K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc. · 2010 · cites it directly24descendants
- K163286ARTIS phenoSiemens Medical Solution USA, Inc. · 2017 · 3 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −5 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −4 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −3 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −2 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −1 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| 0 (this device) | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | — |
| +1 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| +2 | K123529 | Artis Q and Q.Zen- Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2013 | 31 |
| +2 | K122644 | Artis Zee/Zeego with CSX-10 Detector SW VC21 | Siemens Medical Solutions USA, Inc. | 2013 | 1 |
| +1 | K102005 | Allura Xper or Table Series | Philips Medical Systems North America, Inc. | 2010 | 39 |
| +3 | K163286 | ARTIS pheno | Siemens Medical Solution USA, Inc. | 2017 | 14 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 10 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 7 | 0 |
| 2014 | 7 | 0 |
| 2015 | 2 | 0 |
| 2016 | 6 | 1 |
| 2017 | 4 | 2 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 1 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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 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? (2)
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 |
|---|---|---|---|
| * | K021021 | Modular Angiography System Axiom Artis | 2002 |
| * | K052202 | Axiom Artis - Modular Angiographic SystemSummary page 2…510(k) Number Date of Clearance Device Name K(02 1021 June 06, 2002 MODLA ANOIOGRAPIIY SYSTEM AXIOM ARTIS K052202 Murch 07, 2006 AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM The Indication for use of the Artis zee/zeego d… | 2006 |
What descends from it? (72)
See all 723 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 |
|---|---|---|---|---|
| Apr 9, 2019 | Class II | Z-1339-2019 | Software design | In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. |
| Apr 9, 2019 | Class II | Z-1340-2019 | Software design | In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. |
| Oct 26, 2018 | Class II | Z-0558-2019 | Process control | This recall has been initiated due to a possible leakage of a hose in the cooling unit of the X-ray tube. The Artis zee system may lose coolant due to a possible leakage in a hose of the cooling unit in the X-ray tube. This will cause the… |
| Oct 19, 2018 | Class II | Z-0457-2019 | Device Design | Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support |
| Sep 28, 2017 | Class II | Z-0710-2018 | 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… |
| Aug 24, 2017 | Class II | Z-0508-2018 | Employee error | Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to quality standards. A quality inspection will be… |
| Jun 6, 2017 | Class II | Z-0707-2018 | Device Design | Potential for liquid entry |
| Mar 28, 2017 | Class II | Z-1824-2017 | Nonconforming Material/Component | Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functions properly until… |
| Feb 27, 2017 | Class II | Z-1467-2017 | 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… |
| Feb 3, 2017 | Class II | Z-2686-2017 | Component design/selection | Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit. |
| Jul 13, 2016 | Class II | Z-2394-2016 | 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. |
| Jul 7, 2016 | Class II | Z-2344-2016 | Nonconforming Material/Component | Due to an error in the 19 Live Display, image reproduction may fail in the examination room and the potential exists for the loss of images immediately after system startup. |
| Feb 26, 2016 | Class II | Z-1299-2016 | Device Design | In Artis zeego systems, angulations in the vicinity of the C-arm collision area can cause the cable inlet to become clamped and can result in mechanical damage. In Artis systems with A100Plus generators, an attempt to resume operation… |
| Feb 19, 2016 | Class II | Z-1311-2016 | Other | Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. This leak can occur sporadically in affected systems. |
| Feb 18, 2016 | Class II | Z-1284-2016 | Unknown/Undetermined by firm | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can result in a cooling system failure and subsequent system failure. This leak can occur sporadically in affected systems. |
| Feb 18, 2016 | Class II | Z-3093-2017 | Unknown/Undetermined by firm | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems. |
| Feb 18, 2016 | Class II | Z-3095-2017 | Unknown/Undetermined by firm | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems. |
| Feb 18, 2016 | Class II | Z-3099-2017 | Unknown/Undetermined by firm | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems. |
| Feb 18, 2016 | Class II | Z-3094-2017 | Unknown/Undetermined by firm | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems. |
| Feb 18, 2016 | Class II | Z-3096-2017 | Unknown/Undetermined by firm | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems. |
| Feb 18, 2016 | Class II | Z-3092-2017 | Unknown/Undetermined by firm | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems. |
| Feb 18, 2016 | Class II | Z-3097-2017 | Unknown/Undetermined by firm | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems. |
| Feb 18, 2016 | Class II | Z-3098-2017 | Unknown/Undetermined by firm | Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems. |
| Oct 30, 2015 | Class II | Z-0481-2016 | Software design | Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been observed in the field and only sporadic cases have… |
| Jun 29, 2015 | Class II | Z-2340-2015 | 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. |
| Sep 23, 2014 | Class II | Z-0183-2015 | Device Design | A cable inside the C-arm systems may have been routed in an inappropriate manner. Improper routing of the cable may result in increased wear over time. Without additional measures, the potential exists for a cable inside the C-arm to… |
| Sep 17, 2014 | Class II | Z-0854-2015 | Process control | The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible. The Large Focus and Micro Focus focal spots will still be operational without any restriction. Manual switchover is needed… |
| 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. |
| Jun 5, 2014 | Class II | Z-2569-2014 | Software design | There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circumstances, the release of radiation can become blocked… |
| Feb 7, 2014 | Class II | Z-1272-2014 | Device Design | Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure and possible drop out of the gantry system. |
| Feb 7, 2014 | Class II | Z-1309-2014 | Device Design | An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system. |
| Dec 16, 2013 | Class II | Z-1080-2014 | Device Design | During the lifetime of Artis zee Ceiling systems, there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage. |
| Sep 11, 2013 | Class II | Z-0486-2015 | Device Design | There is a potential issue on running Artis systems running software VC1x software if a network problem arises, the function cannot be deactivated again by pressing the "Block Radiation" key on the touch screen control. If this behavior… |
| Jun 26, 2013 | Class II | Z-1782-2013 | Software Design Change | Siemens issued a customer safety advisory notice and field safety corrective action for a potential issue on Artis systems with Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. The issue affects-DSA rotational… |
| Mar 8, 2013 | Class II | Z-0997-2013 | Software design | The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing roadmap OGP (organ program) in the DSA overlay mode may… |
| 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-0485-2010 | Other | c-arm may tilt |
| May 1, 2009 | Not classified | Z-1443-2009 | Other | Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall. |
| Aug 22, 2008 | Not classified | Z-0194-2009 | 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. |
The 5 latest of 39 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 28 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 6 of the 40 ancestors have a recall of any class.
- Of its descendants, K090745 (Siemens Medical Solutions USA, Inc., 2009) has gone furthest, with 69 descendants of its own.
- 4 other devices also cite its predicate K021021.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · IZI
2in 2025
2007high 7 (2007) · low 0 (2015)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
2007high 111 (2014) · low 28 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
2007high 52 (2008) · low 0 (2022)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
2007high 2,171 (2025) · low 14 (2020)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?
Artis zee / zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Procedures that can be performed with the Artis zee / zeego family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Artis zee / zeego can also support the acquisition of position triggered imaging for spatial data synthesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073290: Artis Zee and Zeego.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073290
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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