Data / Medical devices / Finland / Varian Medical Systems Finland 0y
Varian Medical Systems Finland 0y: FDA-registered device maker in Helsinki Uusimaa, Finland, 9 510(k) clearances
Varian Medical Systems Finland 0y is registered with the FDA (registration 3003793371) in Helsinki Uusimaa, Finland. It lists 2 device types. The FDA files 9 510(k) clearances under its listings, the newest dated December 11, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003793371
- Address
- Alvar Aallon katu 5C, Helsinki Uusimaa, Finland, FI-00100
- Owner or operator
- Varian Medical Systems, Inc (2914292)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 3, 2016
- Registered through
- 2027
- Brand names listed
- Eclipse Treatment Planning System, Eclipse Treatment Planning System (v18), Eclipse Treatment Planning System v 15.6, Eclipse Treatment Planning System v16, Eclipse Treatment Planning System v18.1, Ethos Radiotherapy System, Ethos Treatment Management 3, Ethos Treatment Planning 2, Ethos Treatment Management v 2.1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| December 11, 2024 | K242378 | Eclipse Treatment Planning System (18.1) | MUJ | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
| April 30, 2024 | K232923 | Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| May 26, 2023 | K230557 | Eclipse Treatment Planning System (v18.0) | MUJ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| August 20, 2021 | K212294 | Ethos Treatment Management, Ethos Treatment Planning | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| July 10, 2020 | K201607 | Eclipse Treatment Planning System v16.1 | MUJ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| April 3, 2020 | K200608 | Eclipse Treatment Planning System v16.0 | MUJ | 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 |
| May 18, 2018 | K181145 | Eclipse Treatment Planning System | MUJ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| September 18, 2015 | K152393 | Eclipse Treatment Planning System | MUJ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Planning, Radiation Therapy Treatment
- All makers of Accelerator, Linear, Medical
Updated December 11, 2024. 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.