IZI — System, X-Ray, Angiographic Class II
FDA product code IZI covers "System, X-Ray, Angiographic", a Class II medical device regulated under 21 CFR 892.1600. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IZI
- Device Class
- Class II
- Regulation Number
- 892.1600
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261037 | Stryker Endoscopy | 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | May 28, 2026 |
| K253181 | Surgimage Corporation | SURGIMAGE SIM 1000H Fluorescence Imaging Platform | May 13, 2026 |
| K243645 | Diagnostic Green | IC-Flow Imaging System 2.0 | Sep 22, 2025 |
| K243077 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | Affirm 800 | Jun 27, 2025 |
| K231986 | Synaptive Medical | Modus IR | Mar 25, 2024 |
| K234090 | Surgvision | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) | Mar 20, 2024 |
| K231075 | Carl Zeiss Meditec | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) | Jun 20, 2023 |
| K230727 | Novadaq Technologies Ulc (A Part Of Stryker) | SPY Portable Handheld Imaging (SPY-PHI) System | Jun 5, 2023 |
| K222240 | Surgvision | EXPLORER AIR® II | Feb 28, 2023 |
| K214097 | Surgvision | Explorer Air II | Feb 25, 2022 |
| K202391 | Aesculap | DIR 800 | Jan 21, 2021 |
| K192761 | Onlume | Asimov-MKS Imaging System | Jan 17, 2020 |
| K190772 | Olympus Medical Systems | SURGICAL MICROSCOPE SYSTEM ORBEYE with IR | Oct 10, 2019 |
| K182907 | Novadaq Technologies Ulc. (Now A Part Of Stryker) | SPY Elite Intraoperative Perfusion Assessment System | Jan 23, 2019 |
| K181537 | Leica Microsystems (Schweiz) | GLOW800 | Sep 7, 2018 |
| K180019 | Pie Medical Imaging | CAAS Workstation | May 3, 2018 |
| K162991 | Carl Zeiss Meditec | YELLOW 560 Fluorescence Module | Jul 24, 2017 |
| K170239 | Leica Microsystems (Schweiz) | Leica FL560 | Jul 5, 2017 |
| K151780 | Pie Medical Imaging | CAAS Workstation | Mar 11, 2016 |
| K141136 | Leica Biosystems Richmond | LEICA FL800 | Aug 19, 2014 |