Data / Medical devices / United States / Varian Medical Systems, Inc.
Varian Medical Systems, Inc.: FDA-registered device maker in Shoreview, MN, United States, 3 510(k) clearances
Varian Medical Systems, Inc. is registered with the FDA (registration 3022977243) in Shoreview, MN, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 19, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022977243
- Address
- 3550 Lexington Ave N Ste 300, Shoreview, MN, United States, 55126
- Owner or operator
- Varian Medical Systems, Inc (2914292)
- Roles
- Specification developer
- First device listed
- July 25, 2024
- Registered through
- 2026
- Brand names listed
- IntelliBlate Microwave Ablation System Console (IB-CON), IntelliBlate Microwave Ablation System Mobile Cart (IB-CART), IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315), IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320), IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327), OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver, Temperature Sensor Probe (ABL-18TP20)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Biopsy | KNW | 2 | Specification developer | accessdata.fda.gov |
| System, Ablation, Microwave And Accessories | NEY | 2 | 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 |
|---|---|---|---|---|---|---|
| July 19, 2024 | K240480 | IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327) | NEY | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| May 29, 2024 | K240784 | Temperature Sensor Probe (ABL-18TP20) | NEY | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| June 16, 2023 | K230015 | OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver | KNW | Substantially Equivalent | Laurane Medical Sas | accessdata.fda.gov |
Compare with other makers
Updated July 19, 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.