FDA applicant
Accuray Incorporated
FDA records 31 decisions for Accuray Incorporated (Sunnyvale, CA) from 1999 to 2023: 31 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and MUJ (System, Planning, Radiation Therapy Treatment). Since 2016 its 510(k)s took a median of 63 days from receipt to decision, against 94 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 12 of them its own earlier devices. 37 recalls are linked to its devices.
FDA’s records also spell it “Accuray, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Accuray Incorporated’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Accuray Incorporated’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) ReportOther applicant names beginning “Accuray”
FDA records each applicant name separately; these may or may not be the same firm.