IXJClass I
Grid, Radiographic
21 CFR 892.1910 / Radiology
IXJ is the FDA product code for Grid, Radiographic, a class I device type, regulated under 21 CFR 892.1910. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- IXJ
- Device name
- Grid, Radiographic
- Regulation
- 21 CFR 892.1910
- Device class
- Class I
- 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
- 15
- Ingested recalls
- 1
Clearances, product code IXJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1986 | 1 |
| 1988 | 1 |
| 1990 | 1 |
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 2 |
| 1995 | 2 |
| 1996 | 3 |
| 1997 | 1 |
Applicants with the most clearances
Product code IXJ| Applicant | Clearances |
|---|---|
| Eastman Kodak Company | 1 |
| Gendex Corp. | 1 |
| Gilardoni S.p.A. | 1 |
| Infab, LLC. | 1 |
| J.P.I. Chicago Co. | 1 |
| Jpi America, Inc. | 1 |
| Jpi, Inc. | 1 |
| Seibu Techno Coproration | 1 |
| Smit Rontgen | 1 |
| Thermotrex Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Agfa N.V.
- Beekley Corporation
- Del Medical, Inc.
- DHL Supply Chain (Netherlands) B.V.
- Eastman Kodak Company
- Guangzhou Bioway Medical Technology Joint-Stock Co.,Ltd.
- JPI Healthcare Co., Ltd
- Kiran Medical Systems A Div of Trivitron Healthcare Pvt. Ltd
- Mitaya Mfg. Co., Ltd.
- Orthofix SRL
- Philips Electronics Ltd
- Philips Medical Systems DMC GmbH
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.
