# K052202: Axiom Artis - Modular Angiographic System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 7, 2006 after 207 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 29 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K801623 (1980). 33 ancestors in all.
154 later devices descend from it; 2 cite it directly.
4 of 188 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994231: Siemens Integrated Operating System (Sios), Siemens Medical Corp. (2000)
- K042540: Philips IU22 Ultrasound System, Philips Ultrasound, Inc. (2004)

## Cited in the summary but kept off the family tree
- K031359: S-Monovette Edta K2-Gel, Sarstedt, Inc. (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K061054: Axiom Aristos FX Plus (2006), 80 descendants of its own
- K062623: Axiom Luminos DRF (2007), 78 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
- K081722: YSIO (2008), 43 descendants of its own

## Recalls of this device
- Mar 30, 2021 · Class II · Z-1496-2021: Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts which are needed to move system parts (e.g. C-Arm), Increased corrosion may lead to a malfunction of the be
- Jun 12, 2019 · Class II · Z-2018-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2019-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2016-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2023-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2027-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2015-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2025-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2013-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2024-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2012-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2017-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2014-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2026-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2020-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2021-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- Jun 12, 2019 · Class II · Z-2022-2019: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X
- 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
- Jun 6, 2017 · Class II · Z-0708-2018: Potential for liquid entry
- Feb 27, 2017 · Class II · Z-1468-2017: 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
- Nov 1, 2016 · Class II · Z-0603-2017: The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.
- Jan 16, 2012 · Not classified · Z-0927-2012: There is a potential misalignment in the connection of the remote foot switch and the stationary unit. This potential malfunction may occur if either the wireless foot switch or the stationary unit is
- May 1, 2009 · Not classified · Z-1441-2009: Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall.
- Aug 25, 2008 · Not classified · Z-0316-2009: System may switch to emergency fluoroscopy mode.
- Aug 25, 2008 · Not classified · Z-0313-2009: System may switch to emergency fluoroscopy mode.
- Aug 25, 2008 · Not classified · Z-0315-2009: System may switch to emergency fluoroscopy mode.
- Aug 25, 2008 · Not classified · Z-0312-2009: System may switch to emergency fluoroscopy mode.
- Aug 25, 2008 · Not classified · Z-0314-2009: System may switch to emergency fluoroscopy mode.
- Aug 25, 2008 · Not classified · Z-0317-2009: System may switch to emergency fluoroscopy mode.

## 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 etc. AXIOM Artis can also support the acquisition of position triggered imaging for spatial data synthesis. The intended use and indications for use of the AXIOM Artis with wireless footswitch and with voice control as described in its labeling have not changed from its predicate device the AXIOM Artis Modular Angiographic System.

Source page: https://510kreport.com/device/K052202
Methodology: https://510kreport.com/methodology