# K090745: Artis Zee / Zeegos with SW VC14

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 18, 2009 after 90 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K801623 (1980). 41 ancestors in all.
69 later devices descend from it; 5 cite it directly.
4 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073290: Artis Zee and Zeego, Siemens Medical Solutions USA, Inc. (2008) Summary page 2.

## Most influential descendants
- K123529: Artis Q and Q.Zen- Modular Angiographic System (2013), 33 descendants of its own
- K122644: Artis Zee/Zeego with CSX-10 Detector SW VC21 (2013), 30 descendants of its own
- K102005: Allura Xper or Table Series (2010), 24 descendants of its own
- K163286: ARTIS pheno (2017), 23 descendants of its own
- K130638: Alluraclarity Xper FD Series X-Ray System (2013), 18 descendants of its own

## Recalls of this device
- 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
- Jun 26, 2013 · Class II · Z-1782-2013: 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. 
- May 13, 2013 · Class II · Z-1945-2013: Siemens issued a customer safety notice about the overlay of system information after a functional check of the brakes on the Artis Zeego system.
- Mar 8, 2013 · Class II · Z-0997-2013: 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 p
- Jan 31, 2013 · Class II · Z-1750-2013: During the course of product monitoring, Siemens became aware of a tolerance problem in the power supply of the generator control above a specific value, thus, the generator may fail.
- Jan 21, 2013 · Class II · Z-0172-2014: The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the 
- Nov 26, 2012 · Class II · Z-0992-2013: In the course of the firm's product monitoring activities, a potential risk for patient or operators was determined during the operation of an Artis zeego system with software revision VC14, VC20 and 

## 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.

Source page: https://510kreport.com/device/K090745
Methodology: https://510kreport.com/methodology