Product Code: IZW FDA class 2 21 CFR 892.1610

Collimator, Automatic, Radiographic

Radiology

An automatic radiographic collimator is a motorized beam-limiting device that automatically adjusts the X-ray field size to match the image receptor dimensions, minimizing patient radiation exposure without manual adjustment. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IZW, regulated under 21 CFR 892.1610, within the Radiology medical specialty. No special flags apply to this device.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code IZW in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: IZW
Device Class: FDA class 2
Regulation Number: 892.1610
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K101039	SHIMADZU COLLIMATOR R-300	Sep 20, 2010	Substantially Equivalent	Shimadzu Corp.
K093572	R650 QDASM COLLIMATOR	Feb 03, 2010	Substantially Equivalent	Omega Medical Imaging, Inc.
K090578	SHIMADZU COLLIMATOR R-30H	Nov 06, 2009	Substantially Equivalent	Shimadzu Corp.
K091517	RALCO, MODEL R225 ACS	Jul 14, 2009	Substantially Equivalent	Ralco S.R.L.
K083029	MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR	Dec 05, 2008	Substantially Equivalent	Ralco S.R.L.
K072780	MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR	Nov 26, 2007	Substantially Equivalent	Ralco S.R.L.
K073124	COLLIMARE COLLIMATOR FAMILY	Nov 16, 2007	Substantially Equivalent	Collimare, LLC
K050092	R605 FACS COLLIMETER	Jan 31, 2005	Substantially Equivalent	Omega Medical Imaging, Inc.
K031597	DUNLEE FORMAT COLLIMATOR FAMILY	Jul 21, 2003	Substantially Equivalent	Philips Medical Systems North America Co.
K990423	PHILIPS NICOL COLLIMATOR FAMILY	Mar 15, 1999	Substantially Equivalent	Philips Medical Systems, Inc.
K984414	XRE COLLIMATOR WITH SPECTRAL FILTER	Dec 30, 1998	Substantially Equivalent	Trex Medical Corp.
K960998	XRE COLLIMATOR	Apr 03, 1996	Substantially Equivalent	Xre Corp.
K951372	PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE)	May 04, 1995	Substantially Equivalent	Philips Medical Systems, Inc.
K920733	STEREO COLLIMATOR RF-T SERIES	Apr 16, 1992	Substantially Equivalent	Shimadzu Medical Systems
K920725	COLLIMATOR F-20	Apr 16, 1992	Substantially Equivalent	Shimadzu Medical Systems
K911127	COLLIMASTER-90	Sep 19, 1991	Substantially Equivalent	Varian Assoc., Inc.
K894142	ULTRANET-S COLLIMATOR	Nov 06, 1989	Substantially Equivalent	GE Medical Systems
K861942	COLLIMATOR MODEL A280BLE & MODEL A280-BLM	Jul 25, 1986	Substantially Equivalent	D&R X-Ray Products, Inc.
K862340	SENTEC LASER GUIDE LINE, MODEL SGL-05	Jul 11, 1986	Substantially Equivalent	Sentec Corp.
K843244	LIGHT BEAM COLLIMATOR	Sep 14, 1984	Substantially Equivalent	Dealers X-Ray Co., Inc.
K833779	YTTRO FILTER	Jun 05, 1984	Substantially Equivalent	Yttro Corp.
K810598	X-RAY COLLIMATING DEVICES	Apr 10, 1981	Substantially Equivalent	Midmark Corp.
K810590	P.R.M. 80	Apr 10, 1981	Substantially Equivalent	T.E.M. Instruments , Ltd.