# K133580: Artis One

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 28, 2014 after 158 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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: 9 generations back to K801623 (1980). 47 ancestors in all.
11 later devices descend from it; 2 cite 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 2.
- K123529: Artis Q and Q.Zen- Modular Angiographic System, Siemens Medical Solutions USA, Inc. (2013) Summary page 2.
- K042995: X-Leonardo, Siemens Medical Solutions USA, Inc. (2004) Summary page 2.

## Most influential descendants
- 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
- K230949: ARTIS pheno (VE30A) (2023), 3 descendants of its own

## Recalls of this device
- Jan 2, 2025 · Class II · Z-0922-2025: A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the de
- Mar 21, 2023 · Class II · Z-1469-2023: Examination room monitor connected with the hybrid cable may have a display issue and no image function is available
- Sep 21, 2020 · Class II · Z-0298-2021: Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).
- Jan 12, 2018 · Class II · Z-1148-2018: Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt to slide out of its base and the tabletop carriage to slide to the floor.
- Aug 22, 2017 · Class II · Z-0614-2018: The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen
- Mar 11, 2016 · Class II · Z-1282-2016: After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Bi
- Jan 16, 2015 · Class II · Z-1119-2015: The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units.

## Indications for use
Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis one 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. The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.

Source page: https://510kreport.com/device/K133580
Methodology: https://510kreport.com/methodology