Data / Medical devices / Germany / Varian Medical Systems Haan GmbH Manufacturing site Kemnath
Varian Medical Systems Haan GmbH Manufacturing site Kemnath: FDA-registered device maker in Kemnath Bavaria, Germany, 4 510(k) clearances
Varian Medical Systems Haan GmbH Manufacturing site Kemnath is registered with the FDA (registration 3025765259) in Kemnath Bavaria, Germany. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 21, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3025765259
- Address
- Building C10 Roentgenstrasse 19-21, Kemnath Bavaria, Germany, 95478
- Owner or operator
- Varian Medical Systems, Inc (2914292)
- Roles
- Manufacturer
- First device listed
- February 11, 2020
- Registered through
- 2027
- Brand names listed
- Ethos Radiotherapy System, Halcyon, Halcyon Ethos Radiotherapy System, Halcyon, Ethos Radiotherapy System, Halcyon, Ethos Radiotherapy System (5)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 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 |
|---|---|---|---|---|---|---|
| January 21, 2026 | K252977 | Halcyon, Ethos Radiotherapy System (5.0) | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| November 3, 2023 | K232113 | Halcyon, Ethos Radiotherapy System | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| January 17, 2023 | K222941 | Halcyon, Ethos Radiotherapy System | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| February 10, 2020 | K192377 | Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Accelerator, Linear, Medical
- All makers of System, Planning, Radiation Therapy Treatment
Updated January 21, 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.