# K190768: ARTIS icono

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 12, 2019 after 170 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K801623 (1980). 54 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181407: Artis zee/zeego & Artis Q/Q.zen, Siemens Medical Solution USA, Inc. (2018) Summary page 4.
- K133580: Artis One, Siemens Medical Solutions USA, Inc. (2014) Summary page 5.
- K163286: ARTIS pheno, Siemens Medical Solution USA, Inc. (2017) Summary page 5.

## Most influential descendants
- 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
- K230950: ARTIS icono (VE30A) (2023), 3 descendants of its own

## Recalls of this device
- Dec 16, 2022 · Class II · Z-0956-2023: Mechanical connection between the tabletop and table base may be lost.
- 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-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

## 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 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 for diagnosis, surgical planning, interventional procedures and treatment follow-up.

Source page: https://510kreport.com/device/K190768
Methodology: https://510kreport.com/methodology