IZI — System, X-Ray, Angiographic Class II
FDA Device Classification
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 |
|---|
| K243645 | diagnostic green | IC-Flow Imaging System 2.0 | September 22, 2025 |
| K243077 | digital surgery systems, inc. (d.b.a true digital surgery) | Affirm 800 | June 27, 2025 |
| K231986 | synaptive medical | Modus IR | March 25, 2024 |
| K234090 | surgvision | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) | March 20, 2024 |
| K231075 | carl zeiss meditec | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) | June 20, 2023 |
| K230727 | novadaq technologies ulc (a part of stryker) | SPY Portable Handheld Imaging (SPY-PHI) System | June 5, 2023 |
| K222240 | surgvision | EXPLORER AIR® II | February 28, 2023 |
| K214097 | surgvision | Explorer Air II | February 25, 2022 |
| K202391 | aesculap | DIR 800 | January 21, 2021 |
| K192761 | onlume | Asimov-MKS Imaging System | January 17, 2020 |
| K190772 | olympus medical systems | SURGICAL MICROSCOPE SYSTEM ORBEYE with IR | October 10, 2019 |
| K182907 | novadaq technologies ulc. (now a part of stryker) | SPY Elite Intraoperative Perfusion Assessment System | January 23, 2019 |
| K181537 | leica microsystems (schweiz) | GLOW800 | September 7, 2018 |
| K180019 | pie medical imaging | CAAS Workstation | May 3, 2018 |
| K162991 | carl zeiss meditec | YELLOW 560 Fluorescence Module | July 24, 2017 |
| K170239 | leica microsystems (schweiz) | Leica FL560 | July 5, 2017 |
| K151780 | pie medical imaging | CAAS Workstation | March 11, 2016 |
| K141136 | leica biosystems richmond | LEICA FL800 | August 19, 2014 |
| K133719 | hamamatsu photonics k.k | PDE-NEO | March 27, 2014 |
| K133993 | pie medical imaging | CAAS WORKSTATION | March 25, 2014 |