IXRClass II
Table, Radiographic, Tilting
21 CFR 892.1980 / Radiology
IXR is the FDA product code for Table, Radiographic, Tilting, a class II device type, regulated under 21 CFR 892.1980. As of , FDA records hold 77 510(k) clearances under this code, the most recent dated , and 26 recalls.
Classification record
- Product code
- IXR
- Device name
- Table, Radiographic, Tilting
- 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
- 77
- Ingested recalls
- 26
Clearances, product code IXR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 2 |
| 1978 | 1 |
| 1979 | 1 |
| 1980 | 2 |
| 1984 | 3 |
| 1985 | 3 |
| 1986 | 3 |
| 1987 | 3 |
| 1988 | 5 |
| 1989 | 5 |
| 1990 | 7 |
| 1991 | 9 |
| 1992 | 10 |
| 1993 | 2 |
| 1994 | 4 |
| 1995 | 8 |
| 1996 | 1 |
| 1997 | 6 |
| 2000 | 1 |
Applicants with the most clearances
Product code IXR| Applicant | Clearances |
|---|---|
| Fischer Imaging Corp. | 8 |
| Shimadzu Medical Systems | 7 |
| Philips North America LLC | 4 |
| U.S. Imaging Tables, Inc. | 4 |
| General Electric Co. | 3 |
| Siemens Medical Solutions USA, Inc. | 3 |
| Spectrum X-Ray Corp. | 3 |
| Tri W-G, Inc. | 3 |
| Xre Corp. | 3 |
| Bay X-Ray, Inc. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
