# K010721: Axiom Artis Modular Angiography System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Corp.
- Decided: Mar 30, 2001 after 18 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: 26 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
248 later devices descend from it; 2 cite it directly.
4 of 249 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021021: Modular Angiography System Axiom Artis (2002), 218 descendants of its own
- K062623: Axiom Luminos DRF (2007), 78 descendants of its own
- K033244: Digital Fluoroscopic Imaging System, Model Innova 4100 with Tilt Table Option (2003), 75 descendants of its own
- K052412: Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ (2005), 74 descendants of its own
- K073290: Artis Zee and Zeego (2008), 72 descendants of its own

## Recalls of this device
- Sep 28, 2017 · Class II · Z-0711-2018: 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
- Jul 13, 2016 · Class II · Z-2393-2016: 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.
- Jun 29, 2015 · Class II · Z-2342-2015: 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.
- Jun 5, 2014 · Class II · Z-2587-2014: 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.
- Jul 13, 2010 · Not classified · Z-2233-2010: 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 
- Oct 26, 2009 · Not classified · Z-0483-2010: c-arm may tilt
- May 1, 2009 · Not classified · Z-1439-2009: Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall.
- Sep 2, 2008 · Not classified · Z-0128-2009: Incorrect contour finding: Image may be calibrated to the wrong size catheter.
- Sep 2, 2008 · Not classified · Z-0121-2009: Incorrect contour finding: Image may be calibrated to the wrong size catheter.
- Sep 2, 2008 · Not classified · Z-0122-2009: Incorrect contour finding: Image may be calibrated to the wrong size catheter.
- Sep 2, 2008 · Not classified · Z-0123-2009: Incorrect contour finding: Image may be calibrated to the wrong size catheter.
- Sep 2, 2008 · Not classified · Z-0125-2009: Incorrect contour finding: Image may be calibrated to the wrong size catheter.
- Sep 2, 2008 · Not classified · Z-0127-2009: Incorrect contour finding: Image may be calibrated to the wrong size catheter.
- Sep 2, 2008 · Not classified · Z-0120-2009: Incorrect contour finding: Image may be calibrated to the wrong size catheter.
- Sep 2, 2008 · Not classified · Z-0124-2009: Incorrect contour finding: Image may be calibrated to the wrong size catheter.
- Sep 2, 2008 · Not classified · Z-0126-2009: Incorrect contour finding: Image may be calibrated to the wrong size catheter.
- Aug 22, 2008 · Not classified · Z-0193-2009: 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.
- Jan 31, 2007 · Not classified · Z-0578-2007: C-arm gantry could rapidly descend without command during use.
- Jan 31, 2007 · Not classified · Z-0579-2007: C-arm gantry could rapidly descend without command during use
- Apr 11, 2005 · Not classified · Z-0796-05: Live display in exam room may sporadically stop working although the display in the control room remains fully operational
- Apr 1, 2005 · Not classified · Z-0818-05: potential problem with the fluoroscopy switch on the power grip
- Aug 10, 2004 · Not classified · Z-1449-04: Opacification Function of device may incorrectly merge images
- Aug 10, 2004 · Not classified · Z-1450-04: Opacification Function of device may incorrectly merge images
- Jun 2, 2004 · Not classified · Z-1108-04: Error appears in the AUTOMAP function, Module 2, when PERISTEEPING or PERIVISION is activated simultaneously that causes system to crash.
- May 28, 2003 · Not classified · Z-0848-04: patient images misidentified
- Aug 5, 2002 · Not classified · Z-0347-03: Set delay time for contrast injection exceeds 10 seconds, radiation release button is blocked.

Source page: https://510kreport.com/device/K010721
Methodology: https://510kreport.com/methodology