# K103606: Artiste Solution with Sys_VB50 Update

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 15, 2011 after 127 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K914698 (1992). 88 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102671: Syngo RT Therapist Connect Workspace, V4.2, Siemens Medical Solutions USA, Inc. (2010) Summary page 1.
- K072485: Artiste MV SA, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- K060633: Coherence Oncologist Workspace, Model 2.0 and Physicist Workspace, Model 1.0, Siemens Medical Solutions USA, Inc. (2006) Summary page 5.
- K101119: Syngo Dosimetrist Workspace V2.7 Model: 1056864, Siemens Medical Solutions USA, Inc. (2010) Summary page 2.
- K082775: Prescision Option, Siemens Medical Solutions USA, Inc. (2009) Summary page 5.

## Most influential descendants
- K121295: Artistetm Solution with Sys Vcio (2012), 3 descendants of its own
- 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.
- Jul 26, 2016 · Class II · Z-2876-2016: Software patch installation to address several safety issues.
- Aug 5, 2015 · Class II · Z-2812-2015: A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.
- Apr 4, 2013 · Class II · Z-1182-2013: Software update to fix multiple safety related issues.
- Jun 25, 2012 · Class II · Z-2073-2012: Potential safety issue when using the IMMEDIATE RESUMPTION feature after a Control Console interlock during the delivery of flattening-filter-free (Multiple-X) beams or segments. In a very rare scenar
- Apr 3, 2012 · Not classified · Z-1486-2012: SIEMENS has received reports where a dropping down of the 550 TxT" Treatment Table was observed while the table was being moved downwards during operation by means of the hand control.
- Nov 2, 2011 · Not classified · Z-0462-2012: The software release will bring current Installed Base system to the forward production version. It is a result of the final system testing addressing several safety issues that are not critical for t

## 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) and precision stereotactic applications. The stereotactic applications may include single-session radiosurgery, fractionated stereotactic radiation therapy, or fractionated stereotactic intensity modulated radiation therapy for lesions, tumors and conditions anywhere in the head and body where radiation therapy is indicated. The syngo® Suite for Oncology Workspaces: The syngo® workspaces includes a number of syngo® based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording. The syngo® RT Therapist Connect Workspace v4.2, contains software applications that permits patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. The syngo® RT Therapist Connect Workspace v4.2, can be interfaced with third party devices conforming to the DICOM Standard. The syngo® RT Oncologist Workspace permits localization, contouring, segmentation, image calibration, and review 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/K103606
Methodology: https://510kreport.com/methodology