# K132935: Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit, Aria Connectivity Option for Sieme

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 21, 2014 after 156 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K914698 (1992). 105 ancestors in all.
2 later devices descend 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)
- K123812: Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens Non-Imaging Systems, Aria Connectiv, Siemens Medical Solutions USA, Inc. (2013) Summary page 1.
- K121295: Artistetm Solution with Sys Vcio, Siemens Medical Solutions USA, Inc. (2012) Summary page 1.
- K103606: Artiste Solution with Sys_VB50 Update, Siemens Medical Solutions USA, Inc. (2011) Summary page 2.

## Most influential descendants
- K142434: Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist Workspaces, V4.3.1_MR1 (2014), 1 descendant of its own
- 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

## Indications for use
The intended use of the SIEMENS branded ARTISTETM, ONCOR 1 mand PRIMUS1'4 family of linear accelerator systems isto 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 linenr 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 madiation therapy is Indicated. The syngo®D RT Therapist workspace is a component of the linear accelerator system and is based on the syngo& architecture. The syngotD RT Therapist workspace contains software applications to support patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment retarding. The syngo®D RT Therapist Workspace v4.3. 1, can be interfaced with third Part devices conforming to the DICOM Standard.

Source page: https://510kreport.com/device/K132935
Methodology: https://510kreport.com/methodology