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 | August 10, 2011 |
| K101036 | shimadzu | SHIMADZU COLLIMATOR R-20J | August 26, 2010 |
| K042840 | shimadzu | SHIMADZU COLLIMATOR R-20J | December 3, 2004 |
| K031771 | shimadzu | SHIMADZU COLLIMATOR R-30H | August 21, 2003 |
| K981267 | dynarad | FACTS MONOBLOCK | May 6, 1998 |
| K974240 | wuestec medical | LIGHTLINE-M | December 22, 1997 |
| K972966 | applied x-ray technologies | AXT 150M MANUAL COLLIMATOR (AXT 150M) | August 21, 1997 |
| K932134 | rinn | RINN UNIVERSAL COLLIMATOR | July 26, 1993 |
| K912180 | instrumentarium imaging | MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM | October 21, 1991 |
| K900007 | advantech | R-100-ET MANUAL COLLIMATOR | February 6, 1990 |
| K896486 | advantech | R-150-ET COLLIMATOR | January 23, 1990 |
| K874687 | summit industries | COLLI-MATETM MODEL NO. B800 | December 30, 1987 |
| K861941 | d and r x-ray products | COLLIMATOR MODEL A280BLMD & MODEL A280BLMP | July 25, 1986 |
| K840678 | universal x-ray | UXM MODEL 8188 | March 16, 1984 |
| K801168 | ito x-ray | COLLIMAX X-RAY COLLIMATOR # R-182 | July 8, 1980 |
| K780736 | emi medical | CT 5221 DOSE REDUCING COLLIMATORS | June 2, 1978 |
| K771689 | bennett x-ray | DIAL X COLLIMATOR MODEL A&B | September 14, 1977 |