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FDA Product Code

FDA Product Code IZW — Clearance Directory

Device Class
Class II
Assigned Panel
Radiology
21 CFR Citation
892.1610

510(k) Clearances — 23 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K101039 SHIMADZU COLLIMATOR R-300 Shimadzu Corp. 2010-09-20 Abbreviated PDF ↗
K093572 R650 QDASM COLLIMATOR Omega Medical Imaging, Inc. 2010-02-03 Traditional PDF ↗
K090578 SHIMADZU COLLIMATOR R-30H Shimadzu Corp. 2009-11-06 Abbreviated PDF ↗
K091517 RALCO, MODEL R225 ACS Ralco S.R.L. 2009-07-14 Traditional PDF ↗
K083029 MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR Ralco S.R.L. 2008-12-05 Traditional PDF ↗
K072780 MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR Ralco S.R.L. 2007-11-26 Traditional PDF ↗
K073124 COLLIMARE COLLIMATOR FAMILY Collimare, LLC 2007-11-16 Abbreviated PDF ↗
K050092 R605 FACS COLLIMETER Omega Medical Imaging, Inc. 2005-01-31 Traditional PDF ↗
K031597 DUNLEE FORMAT COLLIMATOR FAMILY Philips Medical Systems North America Co. 2003-07-21 Traditional PDF ↗
K990423 PHILIPS NICOL COLLIMATOR FAMILY Philips Medical Systems, Inc. 1999-03-15 Traditional PDF ↗
K984414 XRE COLLIMATOR WITH SPECTRAL FILTER Trex Medical Corp. 1998-12-30 Traditional PDF ↗
K960998 XRE COLLIMATOR Xre Corp. 1996-04-03 Traditional PDF ↗
K951372 PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE) Philips Medical Systems, Inc. 1995-05-04 Traditional PDF ↗
K920725 COLLIMATOR F-20 Shimadzu Medical Systems 1992-04-16 Traditional PDF ↗
K920733 STEREO COLLIMATOR RF-T SERIES Shimadzu Medical Systems 1992-04-16 Traditional PDF ↗
K911127 COLLIMASTER-90 Varian Assoc., Inc. 1991-09-19 Traditional PDF ↗
K894142 ULTRANET-S COLLIMATOR GE Medical Systems 1989-11-06 Traditional PDF ↗
K861942 COLLIMATOR MODEL A280BLE & MODEL A280-BLM D&R X-Ray Products, Inc. 1986-07-25 Traditional PDF ↗
K862340 SENTEC LASER GUIDE LINE, MODEL SGL-05 Sentec Corp. 1986-07-11 Traditional PDF ↗
K843244 LIGHT BEAM COLLIMATOR Dealers X-Ray Co., Inc. 1984-09-14 Traditional PDF ↗
K833779 YTTRO FILTER Yttro Corp. 1984-06-05 Traditional PDF ↗
K810598 X-RAY COLLIMATING DEVICES Midmark Corp. 1981-04-10 Traditional PDF ↗
K810590 P.R.M. 80 T.E.M. Instruments , Ltd. 1981-04-10 Traditional PDF ↗

Product code IZW · Class II · Radiology. Data: openFDA.