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

Accuray Incorporated · Predicate Candidate Screening

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

58 daysmedian FDA review time

116 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K223159	Radixact Treatment Delivery System	Accuray Incorporated	2023-06-23	259	0
K212794	Accuray Precision Treatment Planning System	Accuray Incorporated	2021-09-30	28	0
K202412	ClearRT Helical kVCT for the Radixact Treatment Delivery Sys	Accuray Incorporated	2020-12-18	116	0
K182687	Motion Tracking and Compensation Feature for the Radixact Tr	Accuray Incorporated	2018-11-23	58	0
K171837	TomoTherapy Treatment Delivery System with iDMS	Accuray Incorporated	2017-07-25	35	0
K171086	Accuray Precision Treatment Planning System	Accuray Incorporated	2017-06-08	57	0
K161146	Radixact Treatment Delivery System	Accuray Incorporated	2016-06-24	63	1
K161136	Precision Treatment Planning System	Accuray Incorporated	2016-06-24	63	0
K161144	iDMS Data Management System	Accuray Incorporated	2016-06-24	63	0
K152488	Onrad Treatment System	Accuray Incorporated	2015-09-28	28	0
K150873	CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife	Accuray Incorporated	2015-07-01	91	0
K143269	Delivery Analysis	Accuray Incorporated	2015-04-14	152	0
K122137	CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTI	Accuray Incorporated	2012-10-26	100	4
K121934	TOMOTHERAPY TREATMENT SYSTEM	Accuray Incorporated	2012-08-29	58	3
K120233	SYNCHRONY RESPIRATORY TRACKING SYSTEM	Accuray Incorporated	2012-03-09	44	1
K102650	CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM	Accuray Incorporated	2010-11-17	64	2
K072504	CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM	Accuray Incorporated	2007-09-21	15	7
K071531	MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM	Accuray Incorporated	2007-08-22	78	0
K062514	CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM	Accuray Incorporated	2006-09-28	31	0
K052325	CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY	Accuray Incorporated	2005-09-14	20	1
K042146	ROBOCOUCH PATIENT SUPPORT SYSTEM	Accuray Incorporated	2004-09-17	39	3

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