IZW — Collimator, Automatic, Radiographic Class II
FDA product code IZW covers "Collimator, Automatic, Radiographic", a Class II medical device regulated under 21 CFR 892.1610. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IZW
- 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 |
|---|---|---|---|
| K101039 | shimadzu | SHIMADZU COLLIMATOR R-300 | September 20, 2010 |
| K093572 | omega medical imaging | R650 QDASM COLLIMATOR | February 3, 2010 |
| K090578 | shimadzu | SHIMADZU COLLIMATOR R-30H | November 6, 2009 |
| K091517 | ralco | RALCO, MODEL R225 ACS | July 14, 2009 |
| K083029 | ralco | MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR | December 5, 2008 |
| K072780 | ralco | MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR | November 26, 2007 |
| K073124 | collimare | COLLIMARE COLLIMATOR FAMILY | November 16, 2007 |
| K050092 | omega medical imaging | R605 FACS COLLIMETER | January 31, 2005 |
| K031597 | philips medical systems north america | DUNLEE FORMAT COLLIMATOR FAMILY | July 21, 2003 |
| K990423 | philips medical systems | PHILIPS NICOL COLLIMATOR FAMILY | March 15, 1999 |
| K984414 | trex medical | XRE COLLIMATOR WITH SPECTRAL FILTER | December 30, 1998 |
| K960998 | xre | XRE COLLIMATOR | April 3, 1996 |
| K951372 | philips medical systems | PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE) | May 4, 1995 |
| K920733 | shimadzu medical systems | STEREO COLLIMATOR RF-T SERIES | April 16, 1992 |
| K920725 | shimadzu medical systems | COLLIMATOR F-20 | April 16, 1992 |
| K911127 | varian assoc | COLLIMASTER-90 | September 19, 1991 |
| K894142 | ge medical systems | ULTRANET-S COLLIMATOR | November 6, 1989 |
| K861942 | d and r x-ray products | COLLIMATOR MODEL A280BLE & MODEL A280-BLM | July 25, 1986 |
| K862340 | sentec | SENTEC LASER GUIDE LINE, MODEL SGL-05 | July 11, 1986 |
| K843244 | dealers x-ray co | LIGHT BEAM COLLIMATOR | September 14, 1984 |