Data / Medical devices / United States / Varian Medical Systems, Inc.
Varian Medical Systems, Inc.: FDA-registered device maker in San Jose, CA, United States, 12 510(k) clearances
Varian Medical Systems, Inc. is registered with the FDA (registration 3015548663) in San Jose, CA, United States. It lists 2 device types. The FDA files 12 510(k) clearances under its listings, the newest dated June 3, 2022. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015548663
- Address
- 6212 Hellyer Ave, San Jose, CA, United States, 95138
- Owner or operator
- Varian Medical Systems, Inc (2914292)
- Roles
- Manufacturer
- First device listed
- March 31, 2013
- Registered through
- 2027
- Brand names listed
- Clinac 21 EX, Clinac 2100 C/D, Clinac 2100C, Clinac 23 EX, Clinac 2300 C/D, Clinac Cx, Clinac DHX, Clinac DMX and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer | accessdata.fda.gov |
| Phantom, Anthropomorphic, Radiographic | IXG | 1 | 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 3, 2022 | K213977 | TrueBeam, TrueBeam STx, Edge, VitalBeam | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| April 2, 2018 | K180586 | Varian Head Frame | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| July 28, 2017 | K172013 | VitalBeam | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| July 12, 2017 | K171733 | TrueBeam, TrueBeam STx, Edge | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| January 19, 2017 | K162472 | TrueBeam-TrueBeam STx-Edge | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| December 12, 2016 | K162476 | Varian High Energy Linear Accelerator | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| May 8, 2015 | K150706 | VitalBeam | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| December 19, 2014 | K143224 | TrueBeam-TrueBeam STx-Edge | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| December 11, 2014 | K142560 | Varian Head Frame | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| January 31, 2014 | K133240 | VARIAN MULTILEAF COLLIMATOR | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| October 11, 2013 | K131807 | HIGH ENERGY LINEAR ACCELERATOR | IYE | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| August 15, 2007 | K071992 | HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) | IYE | Substantially Equivalent | Varian Medical Systems | accessdata.fda.gov |
Compare with other makers
Updated June 3, 2022. 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.