FDA applicant

Varian Medical Systems, Oncology Systems

Palo Alto, CA4 decisions2010–20122 recalls

FDA records 4 decisions for Varian Medical Systems, Oncology Systems (Palo Alto, CA) from 2010 to 2012: 4 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and MUJ (System, Planning, Radiation Therapy Treatment). Its devices cite 3 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Varian Medical Systems, Oncology Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2010high 2 (2010) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

2in 2011

2010high 2 (2011) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Varian Medical Systems, Oncology Systems by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Varian Medical Systems, Oncology Systems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Varian”

FDA records each applicant name separately; these may or may not be the same firm.

Varian Medical Systems, Inc. 206 Varian Assoc., Inc. 86 Varian Canada, Inc. 7 Varian, Inc. 5 Varian Medical Systems, X-Ray Products-Infimed 2

Varian Medical Systems, Oncology Systems

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Varian”