IZX

17 FDA 510(k) clearances · Product code

50 daysmedian time to decision

135 days90th percentile

17clearances measured

FDA profile

Official device name: Collimator, Manual, Radiographic
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1610
Medical specialty: Radiology
Adverse events (MAUDE): 1998: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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

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Every clearance here is in the API, with alerts when new ones post.