Data / Medical devices / Germany / Varian Medical Systems Haan GmbH
Varian Medical Systems Haan GmbH: FDA-registered device maker in Haan North Rhine-Westphalia, Germany, 56 510(k) clearances
Varian Medical Systems Haan GmbH is registered with the FDA (registration 3016602874) in Haan North Rhine-Westphalia, Germany. It lists 4 device types. The FDA files 56 510(k) clearances under its listings, the newest dated May 20, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016602874
- Address
- Rheinische Strasse 2, Haan North Rhine-Westphalia, Germany, 42781
- Owner or operator
- Varian Medical Systems, Inc (2914292)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 7, 2007
- Registered through
- 2027
- Brand names listed
- 3D Interstitial Ring Applicator Set 90 degree, APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER, Aarhus Applicator Set, Advanced Breast Template System, BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device, CT/ MR Tandem and Ovoid Set, Catheter Surface Flap Applicator Set, Cervical Sleeves and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Source, Brachytherapy, Radionuclide | KXK | 2 | Manufacturer | accessdata.fda.gov |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| May 20, 2026 | K252717 | MAASTRO Rectal Applicator Set | JAQ | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
| December 16, 2025 | K252919 | IDENTIFY (5.0) | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| November 19, 2025 | K252884 | Guided Aarhus Applicator Set | JAQ | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
| May 9, 2025 | K250299 | CT/ MR Tandem and Ovoid Set | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| April 25, 2025 | K250289 | Intracavitary/Interstitial System | JAQ | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
| March 3, 2025 | K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400) | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| February 7, 2025 | K242957 | Identify (4.0) | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| January 10, 2025 | K241764 | Mould Probe MR Safe | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| November 26, 2024 | K242961 | Intraluminal Applicator Set | JAQ | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
| November 7, 2024 | K241853 | Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| October 29, 2024 | K241965 | Catheter Surface Flap Applicator Set (GM11011830) | JAQ | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
| October 23, 2024 | K241876 | Vitesse (5.0) | MUJ | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
| August 30, 2024 | K241386 | Heyman Packing Applicator Set (GM11004580) | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| May 9, 2024 | K240495 | Flexible Fixation Device for Gynecological Applicators (GM11001960) | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| April 9, 2024 | K232623 | Universal Endometrial Applicator Set (GM11009840) | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| February 1, 2024 | K232949 | Kelowna GYN and Crook Prostate Templates | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| September 8, 2023 | K232400 | VariSeed (v10) | MUJ | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
| July 25, 2023 | K230576 | IDENTIFY | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| March 13, 2023 | K222775 | Aarhus Applicator Set | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| September 14, 2022 | K221797 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| August 17, 2020 | K193240 | Universal Cylinder Applicator Family | JAQ | 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 |
| July 8, 2019 | K191580 | BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| October 22, 2018 | K172533 | GM Implant Tubes, Length Cutting Gauge | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| May 16, 2018 | K172675 | Varian Cervical Sleeves | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| March 21, 2018 | K172611 | Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| February 9, 2018 | K171631 | Standard Catheter Set | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| August 31, 2017 | K162533 | Kelowna GYN and Crook Prostate Templates | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| March 24, 2017 | K162615 | Mould Applicator Set | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| March 10, 2017 | K160815 | Interstitial Needles | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| February 28, 2017 | K162018 | Surface Applicator Set | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| November 17, 2016 | K160045 | Heyman Packing Applicator Set | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| October 20, 2016 | K161540 | Advanced Breast Template System | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| October 2, 2016 | K161576 | Esophagus Bougie Set | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| August 10, 2016 | K160516 | Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| April 13, 2016 | K160021 | Varian Sterilization Boxes | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| December 17, 2015 | K151022 | Intraluminal Applicator Set | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| September 11, 2015 | K152018 | Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| August 7, 2015 | K151657 | Shielded Applicator Set, Cervical Stop | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| July 17, 2015 | K150839 | 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90 | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| March 10, 2015 | K141624 | PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113 | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| August 6, 2014 | K141336 | SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| March 11, 2013 | K123815 | SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| December 7, 2012 | K123152 | VITESSE 3.0 | MUJ | Substantially Equivalent | Varian Medical Systems, Oncology Systems | accessdata.fda.gov |
| July 26, 2012 | K120993 | GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| June 6, 2012 | K120731 | TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| April 27, 2012 | K120341 | PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| March 16, 2012 | K113766 | CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| November 17, 2009 | K093291 | VARIAN INTERSTITIAL TITANIUM NEEDLES | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| February 16, 2005 | K042360 | VARIAN NASOPHARYNX APPLICATOR | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| December 24, 2003 | K033371 | VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS | JAQ | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
| November 26, 2003 | K031524 | GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER | JAQ | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| March 12, 2003 | K030745 | GAMMAMED 212 AND 232 SOURCE ASSEMBLY | KXK | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
| October 29, 1998 | K983436 | GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM | JAQ | Substantially Equivalent | Gammamed USA | accessdata.fda.gov |
| July 26, 1996 | K955844 | APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER | JAQ | Substantially Equivalent | Varian Assoc., Inc. | accessdata.fda.gov |
| November 22, 1995 | K952913 | APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER | JAQ | Substantially Equivalent | Varian Assoc., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Applicator, Radionuclide, Remote-Controlled
- All makers of System, Planning, Radiation Therapy Treatment
- All makers of Source, Brachytherapy, Radionuclide
- All makers of Accelerator, Linear, Medical
Updated May 20, 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.