Collimator, Automatic, Radiographic
Regulation 892.1610
0510(k)s in 12 months (23 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in IZW
| Company | 510(k)s | Recalls |
|---|---|---|
| Ralco S.R.L. | 3 | 0 |
| Shimadzu Medical Systems | 2 | 1 |
| Omega Medical Imaging, Inc. | 2 | 0 |
| Philips Medical Systems, Inc. | 2 | 0 |
| Philips Medical Systems North America Co. Phillips | 0 | 2 |
| Shimadzu Corp. | 2 | 0 |
| Collimare, LLC | 1 | 0 |
| D&R X-Ray Products, Inc. | 1 | 0 |
| Dealers X-Ray Co., Inc. | 1 | 0 |
| GE Medical Systems | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 20, 2010 | K101039 | SHIMADZU COLLIMATOR R-300 Shimadzu Corp. | IZW |
| Feb 3, 2010 | K093572 | R650 QDASM COLLIMATOR Omega Medical Imaging, Inc. | IZW |
| Nov 6, 2009 | K090578 | SHIMADZU COLLIMATOR R-30H Shimadzu Corp. | IZW |
| Jul 14, 2009 | K091517 | RALCO, MODEL R225 ACS Ralco S.R.L. | IZW |
| Dec 5, 2008 | K083029 | MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR Ralco S.R.L. | IZW |
| Nov 26, 2007 | K072780 | MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR Ralco S.R.L. | IZW |
| Nov 16, 2007 | K073124 | COLLIMARE COLLIMATOR FAMILY Collimare, LLC | IZW |
| Jan 31, 2005 | K050092 | R605 FACS COLLIMETER Omega Medical Imaging, Inc. | IZW |
| Jul 21, 2003 | K031597 | DUNLEE FORMAT COLLIMATOR FAMILY Philips Medical Systems North America Co. | IZW |
| Mar 15, 1999 | K990423 | PHILIPS NICOL COLLIMATOR FAMILY Philips Medical Systems, Inc. | IZW |
| Dec 30, 1998 | K984414 | XRE COLLIMATOR WITH SPECTRAL FILTER Trex Medical Corp. | IZW |
| Apr 3, 1996 | K960998 | XRE COLLIMATOR Xre Corp. | IZW |
| May 4, 1995 | K951372 | PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE) Philips Medical Systems, Inc. | IZW |
| Apr 16, 1992 | K920733 | STEREO COLLIMATOR RF-T SERIES Shimadzu Medical Systems | IZW |
| Apr 16, 1992 | K920725 | COLLIMATOR F-20 Shimadzu Medical Systems | IZW |
| Sep 19, 1991 | K911127 | COLLIMASTER-90 Varian Assoc., Inc. | IZW |
| Nov 6, 1989 | K894142 | ULTRANET-S COLLIMATOR GE Medical Systems | IZW |
| Jul 25, 1986 | K861942 | COLLIMATOR MODEL A280BLE & MODEL A280-BLM D&R X-Ray Products, Inc. | IZW |
| Jul 11, 1986 | K862340 | SENTEC LASER GUIDE LINE, MODEL SGL-05 Sentec Corp. | IZW |
| Sep 14, 1984 | K843244 | LIGHT BEAM COLLIMATOR Dealers X-Ray Co., Inc. | IZW |
| Jun 5, 1984 | K833779 | YTTRO FILTER Yttro Corp. | IZW |
| Apr 10, 1981 | K810598 | X-RAY COLLIMATING DEVICES Midmark Corp. | IZW |
| Apr 10, 1981 | K810590 | P.R.M. 80 T.E.M. Instruments , Ltd. | IZW |
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