# K163286: ARTIS pheno - Pathway: 510(k) (Traditional) - Applicant: Siemens Medical Solution USA, Inc. - Decided: Mar 9, 2017 after 107 days - Product code: OWB (Interventional Fluoroscopic X-Ray System) - Device class: 2 - Regulation: 21 CFR 892.1650 - Recalls of this device: 14 (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). 50 ancestors in all. 23 later devices descend from it; 4 cite it directly. 0 of 74 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K123529: Artis Q and Q.Zen- Modular Angiographic System, Siemens Medical Solutions USA, Inc. (2013) Summary page 4. - K122644: Artis Zee/Zeego with CSX-10 Detector SW VC21, Siemens Medical Solutions USA, Inc. (2013) Summary page 5. - K162541: syngo Application Software, Siemens Medical Solutions USA, Inc. (2016) Summary page 5. ## Most influential descendants - K190768: ARTIS icono (2019), 10 descendants of its own - K181550: Cios Spin (2018), 10 descendants of its own - K181560: Cios Alpha (2018), 10 descendants of its own - K203504: Cios Flow (2020), 9 descendants of its own - K201156: ARTIS pheno (VE2) (2020), 5 descendants of its own ## Recalls of this device - Feb 2, 2023 · Class II · Z-1498-2023: If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated when the C-Arm is positioned outside of th - Feb 2, 2023 · Class II · Z-1311-2023: In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment. - Dec 16, 2022 · Class II · Z-0956-2023: Mechanical connection between the tabletop and table base may be lost. - Sep 20, 2022 · Class II · Z-0119-2023: Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued o - 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 - 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 - Apr 22, 2020 · Class II · Z-2108-2020: If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may be impacted or impossible and the area of interest cannot be reached. In the event the C-arms movements - Jan 24, 2020 · Class II · Z-1340-2020: Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the i - Dec 20, 2019 · Class II · Z-0807-2020: The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred. - Jun 6, 2019 · Class II · Z-1905-2019: Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to th - Jul 29, 2018 · Class II · Z-3190-2018: Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit i - Jun 22, 2018 · Class II · Z-2748-2018: Potential hardware issue which may cause thermal effects and possible damage to system parts. - May 30, 2018 · Class II · Z-2524-2018: During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to becom - May 1, 2018 · Class II · Z-2283-2018: If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop u ## 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. 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/K163286 Methodology: https://510kreport.com/methodology