# K201156: ARTIS pheno (VE2)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solution USA, Inc.
- Decided: Jun 29, 2020 after 60 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 6 (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.
5 later devices descend from it; 1 cites it directly.
0 of 61 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.
- K163286: ARTIS pheno, Siemens Medical Solution USA, Inc. (2017) Summary page 5.
- K181407: Artis zee/zeego & Artis Q/Q.zen, Siemens Medical Solution USA, Inc. (2018) Summary page 5.

## Most influential descendants
- K220409: ARTIS pheno (VE21) System (2022), 4 descendants of its own
- K230949: ARTIS pheno (VE30A) (2023), 3 descendants of its own
- K241572: ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) (2024), 2 descendants of its own
- K254173: ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno (2026), 0 descendants of its own
- K253752: ARTIS genio floor; ARTIS icono.explore floor (2026), 0 descendants of its own

## Recalls of this device
- Jun 10, 2022 · Class II · Z-1294-2022: A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video
- Feb 25, 2022 · Class II · Z-0987-2022: 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-0515-2022: 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
- May 27, 2021 · Class II · Z-2029-2021: Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by u
- 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.

## 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/K201156
Methodology: https://510kreport.com/methodology