Data / Medical devices / Switzerland / Varian Medical Systems Imaging Laboratory GmbH
Varian Medical Systems Imaging Laboratory GmbH: FDA-registered device maker in Daettwil, Argovia Aargau, Switzerland, 27 510(k) clearances
Varian Medical Systems Imaging Laboratory GmbH is registered with the FDA (registration 3003094912) in Daettwil, Argovia Aargau, Switzerland. It lists 5 device types. The FDA files 27 510(k) clearances under its listings, the newest dated June 4, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003094912
- Address
- Taefernstrasse 7, Daettwil, Argovia Aargau, Switzerland, CH-5405
- Owner or operator
- Varian Medical Systems, Inc (2914292)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- April 26, 2000
- 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, DoseLab Phantom Set, DoseLab Pro, DoseLab TG-142, Eclipse Treatment Planning System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Manufacturer | accessdata.fda.gov |
| Phantom, Anthropomorphic, Radiographic | IXG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 4, 2026 | K253026 | Respiratory Gating for Scanners (2.1) | JAK | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| December 16, 2025 | K252919 | IDENTIFY (5.0) | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| May 16, 2025 | K250099 | Mobius3D (4.1) | IYE | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
| February 7, 2025 | K242957 | Identify (4.0) | IYE | 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 |
| December 11, 2024 | K242378 | Eclipse Treatment Planning System (18.1) | MUJ | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
| November 21, 2024 | K242874 | Gating Reflector Block | JAK | Substantially Equivalent | Varian Medical Systems, Inc. | 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 |
| July 25, 2023 | K230576 | IDENTIFY | 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 |
| 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 |
| August 20, 2021 | K212294 | Ethos Treatment Management, Ethos Treatment Planning | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| April 20, 2021 | K210835 | Identify | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| January 14, 2021 | K203669 | Mobius3D | 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 |
| November 12, 2019 | K192968 | IDENTIFY | 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 |
| January 17, 2018 | K173838 | ARIA Radiation Therapy Management | IYE | 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 |
| August 13, 2015 | K151533 | Respiratory Gating for Scanners | JAK | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| August 27, 2014 | K141230 | DOSELAB PRO | IYE | Substantially Equivalent | Mobius Medical Systems, LP | accessdata.fda.gov |
| June 23, 2009 | K091209 | PORTALVISION ADVANCED IMAGING | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| October 29, 2004 | K042720 | ON-BOARD IMAGER DEVICE | IYE | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 21, 2022 | 89922 | Class II | Completed | ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1 | Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location | accessdata.fda.gov |
Compare with other makers
- All makers of Accelerator, Linear, Medical
- All makers of System, Planning, Radiation Therapy Treatment
- All makers of System, X-Ray, Tomography, Computed
- All makers of Instrument, Quality-Assurance, Radiologic
- All makers of Phantom, Anthropomorphic, Radiographic
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.