FDA applicant

Accuray Incorportaed

Sunnyvale, CA1 decision2017–20174 recalls

FDA records 1 decision for Accuray Incorportaed (Sunnyvale, CA) in 2017: 1 510(k) clearance. All are in product code IYE (Accelerator, Linear, Medical). Its devices cite 1 predicate, 0 of them its own earlier devices. 4 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 Accuray Incorportaed’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

2in 2026

2017high 2 (2026) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Accuray Incorportaed by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Accuray”

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

Accuray Incorporated 31

Accuray Incorportaed

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Accuray”