Data / Medical devices / Hungary / Varian Medical Systems Hungary Kft.
Varian Medical Systems Hungary Kft.: FDA-registered device maker in Budapest, Hungary, 8 510(k) clearances
Varian Medical Systems Hungary Kft. is registered with the FDA (registration 3010123525) in Budapest, Hungary. It lists 3 device types. The FDA files 8 510(k) clearances under its listings, the newest dated June 4, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3010123525
- Address
- Csorsz utca 45, Budapest, Hungary, 1124
- Owner or operator
- Varian Medical Systems, Inc (2914292)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 31, 2013
- Registered through
- 2027
- Brand names listed
- ARIA Radiation Therapy Management, ARIA Radiation Therapy Management (v16.1 MR3), ARIA Radiation Therapy Management (v18), ARIA Radiation Therapy Management System v18.1, RPM Respiratory Gating System, Respiratory Gating for Scanners, Respiratory Gating for Scanners (2.1), Respiratory Gating for Scanners (RGSC)
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 |
| System, X-Ray, Tomography, Computed | JAK | 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 |
|---|---|---|---|---|---|---|
| June 4, 2026 | K253026 | Respiratory Gating for Scanners (2.1) | JAK | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| December 13, 2024 | K242463 | ARIA Radiation Therapy Management System (18.1) | MUJ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| April 10, 2023 | K230699 | ARIA Radiation Therapy Management (v18.0) | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| June 17, 2022 | K221408 | ARIA Radiation Therapy Management (v16.1 MR3) | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| January 14, 2022 | K213927 | Respiratory Gating for Scanners v2.0 | JAK | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| January 17, 2018 | K173838 | ARIA Radiation Therapy Management | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| August 13, 2015 | K151533 | Respiratory Gating for Scanners | JAK | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| October 15, 2010 | K102024 | RPM RESPIRATORY GATING SYSTEM | IYE | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
Compare with other makers
- All makers of Accelerator, Linear, Medical
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, Planning, Radiation Therapy Treatment
Updated June 4, 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.