Data / Medical devices / Germany / Varian Medical Systems Particle Therapy GmbH & Co. KG
Varian Medical Systems Particle Therapy GmbH & Co. KG: FDA-registered device maker in Troisdorf North Rhine-Westphalia, Germany, 4 510(k) clearances
Varian Medical Systems Particle Therapy GmbH & Co. KG is registered with the FDA (registration 3010658895) in Troisdorf North Rhine-Westphalia, Germany. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated April 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010658895
- Address
- Landgrafenstrasse, Troisdorf North Rhine-Westphalia, Germany, D-53842
- Owner or operator
- Varian Medical Systems, Inc (2914292)
- Roles
- Manufacturer
- First device listed
- August 1, 2014
- Registered through
- 2026
- Brand names listed
- ProBeam 360° Proton Therapy System, ProBeam 360° Proton Therapy System v2 (Multiroom), ProBeam 360° Proton Therapy System v3, ProBeam Proton Therapy System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Radiation Therapy, Charged-Particle, Medical | LHN | 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 |
|---|---|---|---|---|---|---|
| April 23, 2026 | K252815 | ProBeam 360 Proton Therapy System v3.0 | LHN | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| October 6, 2023 | K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) | LHN | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| December 1, 2022 | K221791 | ProBeam 360° Proton Therapy System | LHN | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| January 10, 2014 | K133191 | PROBEAM PROTON THERAPY SYSTEM | LHN | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
Compare with other makers
Updated April 23, 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.