FDA 510(k) Applications for Medical Device Product Code "IZW"
(Collimator, Automatic, Radiographic)

FDA 510(k) Number Applicant Device Name Decision Date
K073124 COLLIMARE, LLC COLLIMARE COLLIMATOR FAMILY 11/16/2007
K050092 OMEGA MEDICAL IMAGING, INC. R605 FACS COLLIMETER 01/31/2005
K093572 OMEGA MEDICAL IMAGING, INC. R650 QDASM COLLIMATOR 02/03/2010
K031597 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. DUNLEE FORMAT COLLIMATOR FAMILY 07/21/2003
K990423 PHILIPS MEDICAL SYSTEMS, INC. PHILIPS NICOL COLLIMATOR FAMILY 03/15/1999
K072780 RALCO S.R.L. MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR 11/26/2007
K083029 RALCO S.R.L. MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR 12/05/2008
K091517 RALCO S.R.L. RALCO, MODEL R225 ACS 07/14/2009
K101039 SHIMADZU CORP. SHIMADZU COLLIMATOR R-300 09/20/2010
K090578 SHIMADZU CORP. SHIMADZU COLLIMATOR R-30H 11/06/2009
K984414 TREX MEDICAL CORP. XRE COLLIMATOR WITH SPECTRAL FILTER 12/30/1998
K960998 XRE CORP. XRE COLLIMATOR 04/03/1996


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