# K141574: Artis Zee/Zeego SW VC21

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 5, 2014 after 85 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K801623 (1980). 44 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122644: Artis Zee/Zeego with CSX-10 Detector SW VC21, Siemens Medical Solutions USA, Inc. (2013) Summary page 5.
- K123529: Artis Q and Q.Zen- Modular Angiographic System, Siemens Medical Solutions USA, Inc. (2013) Summary page 5.

## Most influential descendants
- K181407: Artis zee/zeego & Artis Q/Q.zen (2018), 13 descendants of its own
- K190768: ARTIS icono (2019), 10 descendants of its own
- K201156: ARTIS pheno (VE2) (2020), 5 descendants of its own
- K220432: ARTIS icono (VE21) System (2022), 4 descendants of its own
- K220409: ARTIS pheno (VE21) System (2022), 4 descendants of its own

## Recalls of this device
- May 25, 2018 · Class II · Z-2526-2018: 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
- May 1, 2018 · Class II · Z-2311-2018: 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-2310-2018: 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-2314-2018: 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-2308-2018: 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-2309-2018: 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-2312-2018: 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-2313-2018: 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-0710-2018: 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
- Dec 8, 2016 · Class II · Z-0971-2017: 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-0602-2017: The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.
- May 22, 2015 · Class II · Z-1846-2015: There exists a possible position sensor fault in the swivel base axis not being detected by the system software. When moving, the system could potentially exceed its usual speed, resulting in a collis

## Indications for use
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, 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 zee / zeego can also support the acquisition of position triggered imaging for spatial data synthesis. The Artis zee and Artis zeego include also the software option DynaCT which identifies the Artis as a system with a C-arm CBCT functionality. 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 tissucs as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

Source page: https://510kreport.com/device/K141574
Methodology: https://510kreport.com/methodology