510(k) · Cleared
Recalled · Class II · 2019Artis Q and Q.Zen- 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 Feb 26, 2013 as substantially equivalent to K090745 (Siemens Medical Solutions USA, Inc., 2009) after a 102-day review. Its family tree reaches back 8 generations to 1980. 33 later devices descend from it. It has been recalled 31 times.
- Decided
- Feb 26, 2013
- Review
- 102 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 31
- Predicates
- 1
Its longest line of descent runs back 8 generations to K801623 (1980). 42 ancestors in all. 33 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 7 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 6 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 5 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 4 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 3 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 1 generation backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- This deviceK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013
- Descendant · cites it directly · 23 of its ownK163286 ARTIS phenoSiemens Medical Solution USA, Inc. · 2017 · Recalled
- Descendant · cites it directly · 14 of its ownK141574 Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc. · 2014 · Recalled
- Descendant · cites it directly · 13 of its ownK181407 Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. · 2018 · Recalled
- Descendant · cites it directly · 11 of its ownK133580 Artis OneSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 10 of its ownK190768 ARTIS iconoSiemens Medical Solutions USA, Inc. · 2019 · Recalled
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K163286ARTIS phenoSiemens Medical Solution USA, Inc. · 2017 · cites it directly23descendants
- K141574Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc. · 2014 · cites it directly14descendants
- K181407Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. · 2018 · cites it directly13descendants
- K133580Artis OneSiemens Medical Solutions USA, Inc. · 2014 · cites it directly11descendants
- K190768ARTIS iconoSiemens Medical Solutions USA, Inc. · 2019 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −7 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −6 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −5 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −4 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −3 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −2 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −1 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| 0 (this device) | K123529 | Artis Q and Q.Zen- Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +1 | K163286 | ARTIS pheno | Siemens Medical Solution USA, Inc. | 2017 | 14 |
| +1 | K141574 | Artis Zee/Zeego SW VC21 | Siemens Medical Solutions USA, Inc. | 2014 | 12 |
| +1 | K181407 | Artis zee/zeego & Artis Q/Q.zen | Siemens Medical Solution USA, Inc. | 2018 | 59 |
| +1 | K133580 | Artis One | Siemens Medical Solutions USA, Inc. | 2014 | 7 |
| +2 | K190768 | ARTIS icono | Siemens Medical Solutions USA, Inc. | 2019 | 4 |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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.
Planning a device in OWB? 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? (1)
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 |
|---|---|---|---|
| * | K090745 | Artis Zee / Zeegos with SW VC14Summary page 2…e Device Trade Name: Artis zee and Artis zeego - Modular Angiographic System 510(k) Clearance K090745 Clearance Date June 18, 2009 Classification Name: Angiographic X-Ray System Classification… | 2009 |
What descends from it? (33)
See all 335 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 9, 2019 | Class II | Z-1341-2019 | 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-1342-2019 | 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 19, 2018 | Class II | Z-0458-2019 | 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 |
| Oct 19, 2018 | Class II | Z-0459-2019 | 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 |
| Jul 29, 2018 | Class II | Z-3189-2018 | Device Design | Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g.… |
| Jun 22, 2018 | Class II | Z-2747-2018 | Nonconforming Material/Component | Potential hardware issue which may cause thermal effects and possible damage to system parts. |
| May 1, 2018 | Class II | Z-2307-2018 | Device Design | After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem… |
| May 1, 2018 | Class II | Z-2306-2018 | Device Design | After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem… |
| May 1, 2018 | Class II | Z-2305-2018 | Device Design | After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem… |
| May 1, 2018 | Class II | Z-2303-2018 | Device Design | After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem… |
| May 1, 2018 | Class II | Z-2304-2018 | Device Design | After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem… |
| Sep 28, 2017 | Class II | Z-0709-2018 | 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-0706-2018 | Device Design | Potential for liquid entry |
| Feb 27, 2017 | Class II | Z-1466-2017 | 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 22, 2017 | Class II | Z-1534-2017 | Other | In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator. |
| Dec 8, 2016 | Class II | Z-0972-2017 | Software in the Use Environment | Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following… |
| Nov 1, 2016 | Class II | Z-0601-2017 | 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. |
| Jul 13, 2016 | Class II | Z-2395-2016 | 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 18, 2016 | Class II | Z-3089-2017 | 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-3088-2017 | 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-1283-2016 | 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-3091-2017 | 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-3090-2017 | 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 30, 2015 | Class II | Z-2404-2015 | Software design | in case a system error occurs and the system enters the "Bypass Fluoro" mode while the X-ray locking function is active, the only way to exit the X-ray locking function, would be to either resolve the root cause of the system being in… |
| Jun 29, 2015 | Class II | Z-2341-2015 | 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. |
| Mar 19, 2015 | Class II | Z-1445-2015 | Employee error | potential issue with the Artis Q/ Q zen systems where it is possible that an electrical connection in the equipment cabinet has not been installed correctly. The potentially defective connection in the equipment cabinet will be inspected… |
| Dec 3, 2014 | Class II | Z-0972-2015 | Device Design | Suboptimal routing of the cable may result in increased wear over time. Without additional measures, damage of a cable may result in limited functionality and in rare cases, failure of a system. An ongoing procedure could be terminated in… |
| Dec 5, 2013 | Class II | Z-1202-2014 | Device Design | There exists the possibility that during clinical operation, a breakdown of the x-ray tube could result in loss of x-ray imaging for the Artis Q and Artis Q biplane systems with a flat detector as 40 HDR (large 30x40). |
The 5 latest of 31 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 8 of the 42 ancestors have a recall of any class.
- Of its descendants, K163286 (Siemens Medical Solution USA, Inc., 2017) has gone furthest, with 23 descendants of its own.
- 4 other devices also cite its predicate K090745.
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. 2013, this device’s year, is highlighted.
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?
Artis 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 family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table…
Read the full statement (187 words)
Artis 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 family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions.
Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
The Artis Q and Artis Q.zen include also the software option DynaCT with following IFU:
DynaCT is an x-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.
DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123529 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123529: Artis Q and Q.Zen- Modular Angiographic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123529
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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