KXJClass II
Table, Radiologic
21 CFR 892.1980 / Radiology
KXJ is the FDA product code for Table, Radiologic, a class II device type, regulated under 21 CFR 892.1980. As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and 27 recalls.
Classification record
- Product code
- KXJ
- Device name
- Table, Radiologic
- 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
- 31
- Ingested recalls
- 27
Clearances, product code KXJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 4 |
| 1981 | 4 |
| 1982 | 1 |
| 1984 | 1 |
| 1986 | 3 |
| 1987 | 2 |
| 1988 | 4 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 3 |
| 1996 | 2 |
| 2005 | 1 |
Applicants with the most clearances
Product code KXJ| Applicant | Clearances |
|---|---|
| Philips North America LLC | 3 |
| Siemens Corp. | 3 |
| Continental X-Ray Corp. | 2 |
| Radkor, Inc. | 2 |
| Bay X-Ray, Inc. | 1 |
| Combined Concepts, Inc. | 1 |
| General Electric Co. | 1 |
| General Electrical Espanola, S.A. | 1 |
| Hipoint Research, Inc. | 1 |
| Imatron, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Anholt Technologies Inc.
- Baxter Medical Systems (Suzhou) Co. Ltd
- Baxter Medical Systems GmbH + Co. KG
- Carestream Health, Inc., Global R&D Center
- Compania Mexicana de Radiologia CGR, S.A. de C.V.
- Del Medical, Inc.
- Domico Med-Device, LLC
- ECOTRON Co., Ltd.
- Gabriel Scientific OU
- GE Healthcare
- GE Healthcare (China) Co., Ltd.
- GE Healthcare (Tianjin) Company Limited
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.
