# K193326: ARTIS Icono

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 16, 2020 after 136 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K801623 (1980). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190768: ARTIS icono, Siemens Medical Solutions USA, Inc. (2019) Summary page 4.

## Recalls of this device
- May 20, 2022 · Class II · Z-1342-2022: During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regula
- Apr 11, 2022 · Class II · Z-1245-2022: if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact wit
- Apr 11, 2022 · Class II · Z-1246-2022: if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact wit
- Feb 25, 2022 · Class II · Z-0985-2022: Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to
- Feb 25, 2022 · Class II · Z-0986-2022: Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to
- Feb 25, 2022 · Class II · Z-1339-2022: After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and res
- Oct 12, 2021 · Class II · Z-0516-2022: Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdow
- Oct 12, 2021 · Class II · Z-0517-2022: Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdow
- Mar 19, 2021 · Class II · Z-1497-2021: Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.
- Feb 26, 2021 · Class II · Z-1288-2021: Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.
- Dec 18, 2020 · Class II · Z-1144-2021: Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include System error management,
- Sep 18, 2020 · Class II · Z-0400-2021: There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Pheno systems with software version VE20B. In rare cases, when the DSA acquisition has been started while
- Apr 23, 2020 · Class II · Z-2257-2020: Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in an incorrect diagnosis and inappropriat

## Indications for use
ARTIS 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 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. This does not include projection radiography. 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 can also support the acquisition of position triggered imaging for spatial data synthesis. The ARTIS family include also the software option DynaCT with the following indications for use: DynaCT is an X-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format. DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures of diagnosis, surgical planning, interventional procedures and treatment follow-up.

Source page: https://510kreport.com/device/K193326
Methodology: https://510kreport.com/methodology