IZGClass II
System, X-Ray, Photofluorographic
21 CFR 892.1730 / Radiology
IZG is the FDA product code for System, X-Ray, Photofluorographic, a class II device type, regulated under 21 CFR 892.1730. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- IZG
- Device name
- System, X-Ray, Photofluorographic
- Regulation
- 21 CFR 892.1730
- Device class
- Class II
- Review panel
- Radiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 7
- Ingested recalls
- 0
Clearances, product code IZG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1991 | 2 |
| 1992 | 2 |
| 1996 | 2 |
Applicants with the most clearances
Product code IZG| Applicant | Clearances |
|---|---|
| Advanced Med/Surg, Inc. | 1 |
| B. Braun of America, Inc. | 1 |
| Brotherston/Pxi | 1 |
| GE Healthcare | 1 |
| Oldelft Corp. of America | 1 |
| Shimadzu Medical Systems | 1 |
| Spinal Specialties, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code IZG.
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.
