# K123529: Artis Q and Q.Zen- Modular Angiographic System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 26, 2013 after 102 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 31 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K801623 (1980). 42 ancestors in all.
33 later devices descend from it; 5 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090745: Artis Zee / Zeegos with SW VC14, Siemens Medical Solutions USA, Inc. (2009) Summary page 2.

## Most influential descendants
- K163286: ARTIS pheno (2017), 23 descendants of its own
- K141574: Artis Zee/Zeego SW VC21 (2014), 14 descendants of its own
- K181407: Artis zee/zeego & Artis Q/Q.zen (2018), 13 descendants of its own
- K133580: Artis One (2014), 11 descendants of its own
- K190768: ARTIS icono (2019), 10 descendants of its own

## Recalls of this device
- Apr 9, 2019 · Class II · Z-1341-2019: 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: 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: 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: 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: 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 i
- Jun 22, 2018 · Class II · Z-2747-2018: Potential hardware issue which may cause thermal effects and possible damage to system parts.
- May 1, 2018 · Class II · Z-2307-2018: 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 o
- May 1, 2018 · Class II · Z-2306-2018: 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 o
- May 1, 2018 · Class II · Z-2305-2018: 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 o
- May 1, 2018 · Class II · Z-2303-2018: 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 o
- May 1, 2018 · Class II · Z-2304-2018: 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 o
- Sep 28, 2017 · Class II · Z-0709-2018: 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 lo
- Aug 24, 2017 · Class II · Z-0508-2018: 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 standa
- Jun 6, 2017 · Class II · Z-0706-2018: Potential for liquid entry
- Feb 27, 2017 · Class II · Z-1466-2017: 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 ca
- Feb 22, 2017 · Class II · Z-1534-2017: 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: 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 attemp
- Nov 1, 2016 · Class II · Z-0601-2017: 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: 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: 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: 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 occu
- Feb 18, 2016 · Class II · Z-3088-2017: 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 occu
- Feb 18, 2016 · Class II · Z-1283-2016: 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
- Feb 18, 2016 · Class II · Z-3091-2017: 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 occu
- Feb 18, 2016 · Class II · Z-3090-2017: 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 occu
- Oct 30, 2015 · Class II · Z-0481-2016: 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 
- Jun 30, 2015 · Class II · Z-2404-2015: 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
- Jun 29, 2015 · Class II · Z-2341-2015: 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.
- Mar 19, 2015 · Class II · Z-1445-2015: 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 th
- Dec 3, 2014 · Class II · Z-0972-2015: 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 on
- Dec 5, 2013 · Class II · Z-1202-2014: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K123529
Methodology: https://510kreport.com/methodology