# 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

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 3, 2018 after 64 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: 16 generations back to K914698 (1992). 107 ancestors in all.
No later device cites it as a predicate yet.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142434: Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist Workspaces, V4.3.1_MR1, Siemens Medical Solutions USA, Inc. (2014) Summary page 5.

## 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 Control Console is the operations center for the digital linear accelerator. It contains the digital linear accelerator computer, monitor, and keyboard. From the Control Console, the user can program, initiate, monitor, and control treatments. 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 _MR3, can be interfaced with third party OIS, V&R, TPS, and PACS devices conforming to the DICOM Standard.

Source page: https://510kreport.com/device/K182050
Methodology: https://510kreport.com/methodology