Medical Device Manufacturer · US , Palo Alto , CA

Varian Medical Systems - FDA 510(k) Cleared Devices

32 submissions · 32 cleared · Since 2001

Total

Cleared

Denied

Varian Medical Systems is an American radiation oncology company based in Palo Alto, California. The company develops medical devices and software for cancer treatment and radiotherapy.

Varian Medical Systems has received 32 FDA 510(k) clearances from 32 total submissions since 2001. The company specializes exclusively in Radiology devices, with its latest clearance in 2025, demonstrating continued regulatory activity and innovation in this field.

The company's Radiology portfolio includes linear accelerators, treatment planning systems, applicator sets, and proton therapy systems. These devices support radiotherapy, radiosurgery, brachytherapy, and related oncology applications. Now part of Siemens Healthineers following a 2021 acquisition, Varian continues to operate independently with global manufacturing and distribution capabilities.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the database below.