# K090683: Syngo RT Therapist Connect

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 8, 2009 after 53 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K914698 (1992). 46 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072485: Artiste MV SA, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.
- K060226: Oncor Expression, Siemens Medical Solutions USA, Inc. (2006) Summary page 1.
- K082775: Prescision Option, Siemens Medical Solutions USA, Inc. (2009) Summary page 1.

## Most influential descendants
- K102671: Syngo RT Therapist Connect Workspace, V4.2 (2010), 5 descendants of its own
- K103606: Artiste Solution with Sys_VB50 Update (2011), 4 descendants of its own
- K123812: Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens Non-Imaging Systems, Aria Connectiv (2013), 3 descendants of its own
- 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

## Recalls of this device
- Jul 26, 2016 · Class II · Z-2878-2016: 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.
- Feb 14, 2012 · Not classified · Z-1270-2012: Images used in treatment planning may belong to another patient. Risk of treatment to wrong area. Software update to upgrade Siemens installed base to the latest release of MOSAIQ version 2.00X3 SP5, 
- Jun 29, 2010 · Not classified · Z-1523-2011: A software problem that has the potential for data loss during the transfer of treatment records to the OIS, which may not be recorded in MOSAIQ, and subsequently may lead to mistreatment.

## 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 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 svngo®RT Therapist Connect Workspace: The syngo®RT Therapist Connect Workspace contains software applications that permits patient selection/setup, patient positioning verification, treatment delivery/verification, and treatmint recording. The syngO®RT Therapist Connect Workspace is an option when third party OIS, Treatment Planning Systems and/or PACS devices conforming to the DICOM® Standard are intended to be used in conjunction with the Siemens branded Linear Accelerator system.

Source page: https://510kreport.com/device/K090683
Methodology: https://510kreport.com/methodology