IZI
- Product code
- IZI
- Device name
- System, X-Ray, Angiographic
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.1600
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 6
- Summaries archived here
- 6 (direct download)
- 510(k) clearances (all years, FDA)
- 199 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261037 | 2026-05-28 | Stryker Endoscopy | 780 nm SPY Portable Handheld Imaging (SPY-PHI) Syste… | |
| K253181 | 2026-05-13 | Surgimage Corporation | SURGIMAGE SIM 1000H Fluorescence Imaging Platform | |
| K243645 | 2025-09-22 | Diagnostic Green GmbH | IC-Flow Imaging System 2.0 | |
| K243077 | 2025-06-27 | Digital Surgery Systems, Inc. (D.B.A T… | Affirm 800 | |
| K231986 | 2024-03-25 | Synaptive Medical, Inc. | Modus IR | |
| K234090 | 2024-03-20 | Surgvision GmbH | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® S… |
Official FDA classification page: IZI
Classification and pathway per current FDA publications. Data from openFDA (CC0).