Data / Medical devices / Germany / Siemens Healthineers AG Varian Cancer Therapy (CTH)
Siemens Healthineers AG Varian Cancer Therapy (CTH): FDA-registered device maker in Erlangen Bavaria, Germany, 23 510(k) clearances
Siemens Healthineers AG Varian Cancer Therapy (CTH) is registered with the FDA (registration 3006894636) in Erlangen Bavaria, Germany. It lists 8 device types. The FDA files 23 510(k) clearances under its listings, the newest dated July 10, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3006894636
- Address
- Doris-Ruppenstein-Str. 4, Erlangen Bavaria, Germany, 91052
- Owner or operator
- Varian Medical Systems, Inc (2914292)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- October 3, 2024
- Registered through
- 2027
- Brand names listed
- 3D MLC; MICROMLC; MODULEAF; OPTIFOCUS; SIEMENS IMFAST, 550 TXT TREATMENT TABLE, AI Contouring (VA10A), ARTISTE Solution V4.3; ARTISTE Solution with SYS_VC10, ARTISTE Solution with SYS_VB50; ARTISTE Solution, V4.2, ARTISTE Solution, Sys_VC10C Phase 2 update, with the syngo RT Therapist and RT Oncologist Workspaces, v4.3.1_MR1, ARTISTE; ARTISTE Solution, COHERENCE RTT Connect; syngo RTT Connect and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Specification developer | accessdata.fda.gov |
| Block, Beam-Shaping, Radiation Therapy | IXI | 2 | Specification developer | accessdata.fda.gov |
| Couch, Radiation Therapy, Powered | JAI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Radiological Image Processing Software For Ablation Therapy Planning And Evaluation | QTZ | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Image Processing Software For Radiation Therapy | QKB | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 10, 2026 | K261306 | AI Contouring (VA10A) | QKB | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
| June 16, 2026 | K253264 | myAblation Guide (VC10A) | QTZ | Substantially Equivalent | Siemens Healthcare GmbH | accessdata.fda.gov |
| March 18, 2026 | K252304 | syngo.via RT Image Suite VC10 | MUJ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| August 6, 2024 | K240796 | myAblation Guide (VB80A) | QTZ | Substantially Equivalent | Siemens Healthcare GmbH | accessdata.fda.gov |
| March 8, 2018 | K173625 | syngo.CT Clinical Extensions | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 16, 2015 | K151887 | syngo VSim | MUJ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 21, 2014 | K142434 | ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 | IYE | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 21, 2014 | K132935 | ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEME | IYE | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 1, 2013 | K123812 | COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV | IYE | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 27, 2012 | K121295 | ARTISTETM SOLUTION WITH SYS VCIO | IYE | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 20, 2012 | K120363 | SYNGO RT INTERFACE | MUJ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 15, 2011 | K103606 | ARTISTE SOLUTION WITH SYS_VB50 UPDATE | IYE | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 16, 2010 | K101119 | SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864 | MUJ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 18, 2009 | K092145 | 160MLC OPTION | IYE | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 8, 2009 | K090683 | SYNGO RT THERAPIST CONNECT | IYE | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 27, 2007 | K072485 | ARTISTE MV SA | IYE | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 15, 2006 | K060226 | ONCOR EXPRESSION | IYE | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 18, 2005 | K050422 | 550 TXT TREATMENT TABLE | JAI | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 2, 2003 | K032790 | MICROMLC | IXI | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| September 5, 2003 | K031764 | ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES | IYE | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 8, 2002 | K022307 | KONRAD, MODEL V.2.0 | MUJ | Substantially Equivalent | Mrc Systems GmbH | accessdata.fda.gov |
| November 26, 1999 | K993425 | PRIMUS | IYE | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 3, 1991 | K910971 | Z XT RADIATION THERAPY TREATMENT TABLE | JAI | Substantially Equivalent | Siemens Medical Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Accelerator, Linear, Medical
- All makers of Radiological Image Processing Software For Radiation Therapy
- All makers of Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
- All makers of Block, Beam-Shaping, Radiation Therapy
- All makers of System, Planning, Radiation Therapy Treatment
- All makers of Couch, Radiation Therapy, Powered
Updated July 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.