# K060633: Coherence Oncologist Workspace, Model 2.0 and Physicist Workspace, Model 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 1, 2006 after 53 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K914698 (1992). 28 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031764: Oncor Avant-Garde with Coherence Workspaces, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.
- K040970: Leonardo, Siemens Medical Systems, Inc. (2004) Summary page 1.
- K935928: Rit 113 Film Analysis System, Radiological Imaging Technology, Inc. (1994) Summary page 1.

## Most influential descendants
- K103606: Artiste Solution with Sys_VB50 Update (2011), 4 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
- 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
- Jan 16, 2020 · Class II · Z-1346-2020: A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in incorrect offset values which could lead

## Indications for use
The intended use of the COHERENCE Workspaces are as optional accessories to the linear accelerator systems to aid and support in the quality assurance, planning and delivery of x-ray radiation for the therapeutic treatment of cancer. The COHERENCE Workspaces encompasses a number of syngo software applications who's indication for use include the viewing, manipulation, filming, communications, and archiving of medical images and data on exchange media. The COHERENCE Oncologist Workspace permits localization, contouring, image calibration and conditioning, and review of treatment parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy. The indications for use for the COHERENCE Oncologist 2.0 workspace remain unchanged from the previously cleared COHERENCE Oncologist workspace (K031764). The COHERENCE Physicist Workspace is a syngo software application package for the use with radiation therapy devices for viewing, manipulation, image calibration and conditioning, communication and storage of medical images and data on exchange media; and as a quality assurance tool for radiation therapy linear accelerators and their accessories.

Source page: https://510kreport.com/device/K060633
Methodology: https://510kreport.com/methodology