# K123812: Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens Non-Imaging Systems, Aria Connectiv

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 1, 2013 after 80 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K914698 (1992). 48 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090683: Syngo RT Therapist Connect, Siemens Medical Solutions USA, Inc. (2009) Summary page 1.
- K092145: 160MLC Option, Siemens Medical Solutions USA, Inc. (2009) Summary page 1.
- K060226: Oncor Expression, Siemens Medical Solutions USA, Inc. (2006) Summary page 1.

## 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
- Mar 5, 13 · Class II · Z-1042-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin
- Mar 5, 13 · Class II · Z-1038-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin
- Mar 5, 13 · Class II · Z-1037-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin
- Mar 5, 13 · Class II · Z-1040-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin
- Mar 5, 13 · Class II · Z-1041-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin
- Mar 5, 13 · Class II · Z-1043-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin
- Mar 5, 13 · Class II · Z-1036-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin
- Mar 5, 13 · Class II · Z-1039-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin
- Mar 5, 13 · Class II · Z-1044-2013: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testin

## 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. COHERENCE RT Therapist is a component of the linear accelerator system and is based on the syngo architecture. It enables patient management, patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. COHERENCE RT Therapist Workspace Connect v2.3 can be Interfaced with 3rd party devices conforming to the DICOM standard.

Source page: https://510kreport.com/device/K123812
Methodology: https://510kreport.com/methodology