IZZClass II
Table, Radiographic, Non-Tilting, Powered
21 CFR 892.1980 / Radiology
IZZ is the FDA product code for Table, Radiographic, Non-Tilting, Powered, a class II device type, regulated under 21 CFR 892.1980. As of , FDA records hold 29 510(k) clearances under this code, the most recent dated , and 19 recalls.
Classification record
- Product code
- IZZ
- Device name
- Table, Radiographic, Non-Tilting, Powered
- Regulation
- 21 CFR 892.1980
- 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
- 29
- Ingested recalls
- 19
Clearances, product code IZZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1979 | 1 |
| 1982 | 1 |
| 1984 | 2 |
| 1986 | 1 |
| 1988 | 2 |
| 1989 | 4 |
| 1990 | 2 |
| 1991 | 3 |
| 1992 | 3 |
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 3 |
| 1997 | 1 |
Applicants with the most clearances
Product code IZZ| Applicant | Clearances |
|---|---|
| Continental X-Ray Corp. | 3 |
| General Electric Co. | 3 |
| Shimadzu Medical Systems | 3 |
| Toshiba America Medical Systems, In.C | 2 |
| Alimed, LLC | 1 |
| Bennett X-Ray Corp. | 1 |
| Biodan Medical Systems, Ltd. | 1 |
| Control-X, Inc. | 1 |
| D&R X-Ray Products, Inc. | 1 |
| Fischer Imaging Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Accogent Pausch
- Arcoma AB
- Carestream Health, Inc., Global R&D Center
- Del Medical, Inc.
- DK Medical Systems Co., Ltd.
- Drgem Corporation
- DRGEM Corporation (Gimcheon Factory)
- Eastman Kodak Company
- GE Hangwei Medical Systems, Co. Ltd
- GE Healthcare (China) Co., Ltd.
- GE Healthcare Japan Corporation
- GE Medical Systems Israel, Functional Imaging
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.
