# K121295: Artistetm Solution with Sys Vcio

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 27, 2012 after 58 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: 13 generations back to K914698 (1992). 102 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103606: Artiste Solution with Sys_VB50 Update, Siemens Medical Solutions USA, Inc. (2011) Summary page 2.
- K052315: Simtec IM-Maxx 2 Option, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.
- K072916: Trilogy System with Rapidarc, Varian Medical Systems, Inc. (2007) Summary page 1.
- K052423: Magnetom Systems with Syngo Expert - I Option, Siemens Medi Cal Solutions, Inc. (2006) Summary page 2.

## Most influential descendants
- K132935: Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit, Aria Connectivity Option for Sieme (2014), 2 descendants of its own
- 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

## Recalls of this device
- Feb 18, 2020 · Class II · Z-1677-2020: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
- Mar 20, 2019 · Class II · Z-1204-2019: Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collision with LINA
- Feb 14, 2018 · Class II · Z-1401-2018: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
- May 29, 2013 · Class II · Z-1562-2013: The potential for a safety issue, for the image quality degradation, that is addressed by the Customer Safety Advisory Notice when verifying the patient position based on 2D images that were acquired 
- Jan 17, 2013 · Class II · Z-0907-2013: Siemens became aware of a potential safety issue when using the "In-session resumption" feature of the syngo RT Therapist (RTT) 4.3 software. The RTT will send again the previously completed beam or s

## Indications for use
The intended use of the SIEMENS branded ARTISTETI, ONCORrM and PRI~hIlJSTMv family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The linear acceler-ator systems are high-dose and high-dose rate medical linear accelerators optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT), moduilated 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® Suite for Oncologv Worksvaces: The syngo® workspaces includes a number of syngo®& based, clinically focused advanced software applications that include patient data management, remote user communication within a local network, and the viewing, processing, manipulation, filming, and archiving of medical images. The syngoO Wr'Therapist Workspace v4.3, contains software applications that permits patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. The syngo®DRT Therapist Workspace v4.3, can be interfaced with third party devices conforming to the DICOM Standard. The syngo® RT Oncologist Workspace v4.3 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.

Source page: https://510kreport.com/device/K121295
Methodology: https://510kreport.com/methodology