IZIClass II
System, X-Ray, Angiographic
21 CFR 892.1600 / Radiology
IZI is the FDA product code for System, X-Ray, Angiographic, a class II device type, regulated under 21 CFR 892.1600. As of , FDA records hold 199 510(k) clearances under this code, the most recent dated , and 259 recalls.
Classification record
- Product code
- IZI
- Device name
- System, X-Ray, Angiographic
- Regulation
- 21 CFR 892.1600
- 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
- No
- Ingested clearances
- 199
- Ingested recalls
- 259
Clearances, product code IZI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1981 | 5 |
| 1982 | 1 |
| 1984 | 3 |
| 1985 | 2 |
| 1986 | 1 |
| 1988 | 15 |
| 1989 | 5 |
| 1990 | 8 |
| 1991 | 11 |
| 1992 | 18 |
| 1993 | 10 |
| 1994 | 12 |
| 1995 | 14 |
| 1996 | 3 |
| 1997 | 14 |
| 1998 | 4 |
| 1999 | 6 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 3 |
| 2004 | 5 |
| 2005 | 4 |
| 2006 | 4 |
| 2007 | 7 |
| 2008 | 6 |
| 2009 | 2 |
| 2010 | 2 |
| 2011 | 4 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 4 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 2 |
Applicants with the most clearances
Product code IZI| Applicant | Clearances |
|---|---|
| Philips North America LLC | 18 |
| Siemens Medical Solutions USA, Inc. | 14 |
| GE Healthcare | 13 |
| Xre Corp. | 10 |
| Novadaq Technologies ULC | 9 |
| Shimadzu Medical Systems | 8 |
| Shimadzu Precision Instruments, Inc. | 8 |
| Paieon, Inc. | 7 |
| Shimadzu Corp. | 6 |
| Siemens Gammasonics, Inc. | 5 |
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.