Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Accuray, Inc. — Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

65 daysmedian FDA review time

203 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K091999	CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM	Accuray, Inc.	2009-09-18	78	3
K091146	MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM	Accuray, Inc.	2009-05-01	11	3
K062967	CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM	Accuray, Inc.	2006-10-30	31	0
K051941	CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM	Accuray, Inc.	2005-08-09	22	0
K041315	CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY	Accuray, Inc.	2004-06-10	24	0
K032345	CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY	Accuray, Inc.	2003-09-03	35	0
K020294	MOTION TRACKING	Accuray, Inc.	2002-04-22	84	2
K011024	CYBERKNIFE SYSTEM	Accuray, Inc.	2001-08-10	128	2
K000478	THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTH	Accuray, Inc.	2000-04-19	65	0
K984563	THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHE	Accuray, Inc.	1999-07-14	203	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda