Collimator, Manual, Radiographic
Regulation 892.1610
0510(k)s in 12 months (17 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in IZX
| Company | 510(k)s | Recalls |
|---|---|---|
| Summit Industries, Inc. | 1 | 3 |
| Shimadzu Corp. | 3 | 0 |
| Advantech | 2 | 0 |
| Applied X-Ray Technologies, Inc. | 1 | 0 |
| Bennett X-Ray Corp. | 1 | 0 |
| D&R X-Ray Products, Inc. | 1 | 0 |
| Dynarad Corp. | 1 | 0 |
| Emi Medical, Inc. | 1 | 0 |
| Instrumentarium Imaging, Inc. | 1 | 0 |
| Ito X-Ray Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 10, 2011 | K110856 | RALCO Ralco S.R.L. | IZX |
| Aug 26, 2010 | K101036 | SHIMADZU COLLIMATOR R-20J Shimadzu Corp. | IZX |
| Dec 3, 2004 | K042840 | SHIMADZU COLLIMATOR R-20J Shimadzu Corp. | IZX |
| Aug 21, 2003 | K031771 | SHIMADZU COLLIMATOR R-30H Shimadzu Corp. | IZX |
| May 6, 1998 | K981267 | FACTS MONOBLOCK Dynarad Corp. | IZX |
| Dec 22, 1997 | K974240 | LIGHTLINE-M Wuestec Medical, Inc. | IZX |
| Aug 21, 1997 | K972966 | AXT 150M MANUAL COLLIMATOR (AXT 150M) Applied X-Ray Technologies, Inc. | IZX |
| Jul 26, 1993 | K932134 | RINN UNIVERSAL COLLIMATOR Rinn Corp. | IZX |
| Oct 21, 1991 | K912180 | MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM Instrumentarium Imaging, Inc. | IZX |
| Feb 6, 1990 | K900007 | R-100-ET MANUAL COLLIMATOR Advantech | IZX |
| Jan 23, 1990 | K896486 | R-150-ET COLLIMATOR Advantech | IZX |
| Dec 30, 1987 | K874687 | COLLI-MATETM MODEL NO. B800 Summit Industries, Inc. | IZX |
| Jul 25, 1986 | K861941 | COLLIMATOR MODEL A280BLMD & MODEL A280BLMP D&R X-Ray Products, Inc. | IZX |
| Mar 16, 1984 | K840678 | UXM MODEL 8188 Universal X-Ray | IZX |
| Jul 8, 1980 | K801168 | COLLIMAX X-RAY COLLIMATOR # R-182 Ito X-Ray Corp. | IZX |
| Jun 2, 1978 | K780736 | CT 5221 DOSE REDUCING COLLIMATORS Emi Medical, Inc. | IZX |
| Sep 14, 1977 | K771689 | DIAL X COLLIMATOR MODEL A&B Bennett X-Ray Corp. | IZX |
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