IZX — Collimator, Manual, Radiographic Class II
FDA product code IZX covers "Collimator, Manual, Radiographic", a Class II medical device regulated under 21 CFR 892.1610. Submissions are reviewed by the Radiology panel. At least 17 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IZX
- Device Class
- Class II
- Regulation Number
- 892.1610
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K110856 | Ralco | RALCO | Aug 10, 2011 |
| K101036 | Shimadzu | SHIMADZU COLLIMATOR R-20J | Aug 26, 2010 |
| K042840 | Shimadzu | SHIMADZU COLLIMATOR R-20J | Dec 3, 2004 |
| K031771 | Shimadzu | SHIMADZU COLLIMATOR R-30H | Aug 21, 2003 |
| K981267 | Dynarad | FACTS MONOBLOCK | May 6, 1998 |
| K974240 | Wuestec Medical | LIGHTLINE-M | Dec 22, 1997 |
| K972966 | Applied X-Ray Technologies | AXT 150M MANUAL COLLIMATOR (AXT 150M) | Aug 21, 1997 |
| K932134 | Rinn | RINN UNIVERSAL COLLIMATOR | Jul 26, 1993 |
| K912180 | Instrumentarium Imaging | MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM | Oct 21, 1991 |
| K900007 | Advantech | R-100-ET MANUAL COLLIMATOR | Feb 6, 1990 |
| K896486 | Advantech | R-150-ET COLLIMATOR | Jan 23, 1990 |
| K874687 | Summit Industries | COLLI-MATETM MODEL NO. B800 | Dec 30, 1987 |
| K861941 | D And R X-Ray Products | COLLIMATOR MODEL A280BLMD & MODEL A280BLMP | Jul 25, 1986 |
| K840678 | Universal X-Ray | UXM MODEL 8188 | Mar 16, 1984 |
| K801168 | Ito X-Ray | COLLIMAX X-RAY COLLIMATOR # R-182 | Jul 8, 1980 |
| K780736 | Emi Medical | CT 5221 DOSE REDUCING COLLIMATORS | Jun 2, 1978 |
| K771689 | Bennett X-Ray | DIAL X COLLIMATOR MODEL A&B | Sep 14, 1977 |