# K142434: Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist Workspaces, V4.3.1_MR1

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 21, 2014 after 84 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K914698 (1992). 106 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132935: Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit, Aria Connectivity Option for Sieme, Siemens Medical Solutions USA, Inc. (2014) Summary page 4.
- K121295: Artistetm Solution with Sys Vcio, Siemens Medical Solutions USA, Inc. (2012) Summary page 5.

## Most influential descendants
- K182050: Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch (2018), 0 descendants of its own

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0472-2023: When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter
- Dec 9, 2021 · Class II · Z-0441-2022: Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in se
- Aug 11, 2015 · Class II · Z-0106-2016: This update is intended to provide a software update for the Syngo RT Oncologist, which is currently running SW version 4.2 or 4.3. The safety-related issues, which were described in the Customer Safe
- May 5, 2015 · Class II · Z-0168-2016: potential safety risk of collision of the LINAC gantry with the patient or the treatment table in case of automatically sequenced treatment delivery techniques using SIMTEC" Auto Field Sequence Option
- Jan 2, 2015 · Class II · Z-1013-2015: Combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registration in Adaptive Targeting might result in wrong offset calculations. Applying this offset can lead to p

## Indications for use
The intended use of the SIEMENS branded ARTISTE™, ONCOR™ and PRIMUS™ family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. The linear accelerator systems are high-dose and high-dose rate medical linear accelerators optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT), modulated arc therapy (mARC) and precision stereotactic radiation therapy for lesions, tumors and conditions anywhere in the head and body where radiation therapy is indicated. The syngo® RT Therapist Workspace is a component of the linear accelerator system and is based on the syngo® architecture. The syngo® RT Therapist workspace contains software applications to support patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. The syngo® RT Oncologist Workspace is an optional accessory to the linear accelerator system and permits localization, contouring, segmentation, image review, and review and approval of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy. The syngo® RT Therapist and the syngo® RT Oncologist Workspaces v4.3.1_MR1, can be interfaced with third party OIS, V&R, TPS, and PACS devices conforming to the DICOM Standard.

Source page: https://510kreport.com/device/K142434
Methodology: https://510kreport.com/methodology