Varian Medical Systems, Inc. - FDA 510(k) Cleared Devices

Varian Medical Systems, Inc. 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, Inc. has received 169 FDA 510(k) clearances from 169 total submissions since its first clearance in 1997. The company's regulatory portfolio is dominated by Radiology devices, representing 96% of all submissions. The latest FDA 510(k) clearance was granted in 2026, demonstrating continued regulatory activity.

The company specializes in linear accelerators (LINACs), radiation therapy management systems, and brachytherapy applicators. Varian Medical Systems, Inc. also provides software solutions for cancer clinics and radiotherapy centers. Now part of Siemens Healthineers following a 2021 acquisition, the brand continues to operate independently with its original headquarters and workforce intact.

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

510(k) submissions have been managed by Varian Medical Systems, Inc. as regulatory consultant.