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

Viewray, Incorporated — Predicate Candidate Screening

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

182 daysmedian FDA review time

327 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K212958	MRIdian Linac System	Viewray, Incorporated	2021-12-14	89	0
K181989	MRIdian Linac System	Viewray, Incorporated	2019-02-20	209	0
K170751	MRIdian Linac System with 138-leaf Collimator	Viewray, Incorporated	2017-06-07	86	1
K162393	The ViewRay (MRIdian) Linac System	Viewray, Incorporated	2017-02-24	182	0
K111862	VIEWRAY SYSTEM	Viewray, Incorporated	2012-05-22	327	7
K102915	VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM	Viewray, Incorporated	2011-01-12	103	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