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

IZX — Predicate Candidate Screening

17 FDA 510(k) clearances under this product code; the 50 most recent screened below.

50 daysmedian FDA review time

135 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K110856	RALCO	Ralco S.R.L.	2011-08-10	135	0
K101036	SHIMADZU COLLIMATOR R-20J	Shimadzu Corp.	2010-08-26	134	1
K042840	SHIMADZU COLLIMATOR R-20J	Shimadzu Corp.	2004-12-03	50	0
K031771	SHIMADZU COLLIMATOR R-30H	Shimadzu Corp.	2003-08-21	73	0
K981267	FACTS MONOBLOCK	Dynarad Corp.	1998-05-06	29	0
K974240	LIGHTLINE-M	Wuestec Medical, Inc.	1997-12-22	40	0
K972966	AXT 150M MANUAL COLLIMATOR (AXT 150M)	Applied X-Ray Technologies, Inc.	1997-08-21	10	0
K932134	RINN UNIVERSAL COLLIMATOR	Rinn Corp.	1993-07-26	84	0
K912180	MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM	Instrumentarium Imaging, Inc.	1991-10-21	158	0
K900007	R-100-ET MANUAL COLLIMATOR	Advantech	1990-02-06	35	0
K896486	R-150-ET COLLIMATOR	Advantech	1990-01-23	71	0
K874687	COLLI-MATETM MODEL NO. B800	Summit Industries, Inc.	1987-12-30	47	3
K861941	COLLIMATOR MODEL A280BLMD & MODEL A280BLMP	D&R X-Ray Products, Inc.	1986-07-25	66	0
K840678	UXM MODEL 8188	Universal X-Ray	1984-03-16	30	0
K801168	COLLIMAX X-RAY COLLIMATOR # R-182	Ito X-Ray Corp.	1980-07-08	54	0
K780736	CT 5221 DOSE REDUCING COLLIMATORS	Emi Medical, Inc.	1978-06-02	32	0
K771689	DIAL X COLLIMATOR MODEL A&B	Bennett X-Ray Corp.	1977-09-14	8	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