IZXClass II
Collimator, Manual, Radiographic
21 CFR 892.1610 / Radiology
IZX is the FDA product code for Collimator, Manual, Radiographic, a class II device type, regulated under 21 CFR 892.1610. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and 4 recalls.
Classification record
- Product code
- IZX
- Device name
- Collimator, Manual, Radiographic
- Regulation
- 21 CFR 892.1610
- Device class
- Class II
- Review panel
- Radiology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 17
- Ingested recalls
- 4
Clearances, product code IZX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1980 | 1 |
| 1984 | 1 |
| 1986 | 1 |
| 1987 | 1 |
| 1990 | 2 |
| 1991 | 1 |
| 1993 | 1 |
| 1997 | 2 |
| 1998 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2010 | 1 |
| 2011 | 1 |
Applicants with the most clearances
Product code IZX| Applicant | Clearances |
|---|---|
| Shimadzu Corp. | 3 |
| Advantech Corporation | 2 |
| Applied X-Ray Technologies, Inc. | 1 |
| Bennett X-Ray Corp. | 1 |
| D&R X-Ray Products, Inc. | 1 |
| Dynarad Corp. | 1 |
| Emi Medical, Inc. | 1 |
| Instrumentarium Imaging, Inc. | 1 |
| Ito X-Ray Corp. | 1 |
| Ralco S.r.l. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Accogent Pausch
- Collimare, LLC
- Del Medical, Inc.
- Dentsply LLC
- Drgem Corporation
- DRGEM Corporation (Gimcheon Factory)
- Fairy Medical Electrics(jiaxing)co.,Ltd
- Huestis Machine Corp.
- iRay Imaging Technology (Haining) Limited
- Philips Medical Systems Nederland B.V.
- Ralco S.r.l.
- Shimadzu Corporation Medical Systems Division
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.