# K021021: Modular Angiography System Axiom Artis

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 6, 2002 after 69 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K890348 (1989). 5 ancestors in all.
218 later devices descend from it; 5 cite it directly.
4 of 224 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010721: Axiom Artis Modular Angiography System, Siemens Medical Corp. (2001) Summary page 1.
- K993037: LCV+ Version 2, Ge Medical Systems, Inc. (2000) Summary page 1.
- (no number) Philips Integris Allura Flat Detector system: named in the summary without a submission number

## Most influential descendants
- 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
- K090745: Artis Zee / Zeegos with SW VC14 (2009), 69 descendants of its own

## Recalls of this device
- May 25, 2018 · Class II · Z-2525-2018: 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
- Jan 5, 2018 · Class II · Z-1150-2018: Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or restart the 
- 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
- Feb 19, 2016 · Class II · Z-1310-2016: Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. This leak can occur sporadically in affected systems.
- Apr 26, 2013 · Class II · Z-2108-2013: The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used.
- Sep 9, 2010 · Not classified · Z-0144-2011: Sporadic system crash while Perivision is performed.
- 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 
- Apr 12, 2010 · Not classified · Z-1732-2010: sporadic malfunctions of the Artis Systems with Motor Controller caused by tolerances on electronic parts that might increase during the lifetime of the system.
- Mar 4, 2010 · Not classified · Z-1237-2010: Due to a contact problem at the low voltage power supply of the generator controller, in rare cases where a user has invoked radiation, it may occur that no radiation is released. Under certain circum
- Feb 16, 2010 · Not classified · Z-1312-2010: Communication problems can occur which may result in unavailability of Bypass Fluoro.
- Oct 26, 2009 · Not classified · Z-0484-2010: c-arm may tilt
- May 1, 2009 · Not classified · Z-1440-2009: 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.

## Indications for use
AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro-angiography, general angiography, operating room angiography, multipurpose angiography and radiographic/fluoroscopic procedures e.g. Gastro-intestinal imaging, Skeletal imaging ctc. AXIOM Arttis can also support the acquisition of position triggered imaging for spatial data synthesis. The intended use and indications for use of the Modular Angiography System AXIOM Artis with Flat Panel Detector as described in its labeling have not changed from its predicate device AXIOM Artis with the image intensifier.

Source page: https://510kreport.com/device/K021021
Methodology: https://510kreport.com/methodology