IZI · System, X-Ray, Angiographic
Radiology · 21 CFR 892.1600 · Class 2
Overview
| Product Code | IZI |
|---|---|
| Device Name | System, X-Ray, Angiographic |
| Regulation | 21 CFR 892.1600 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 197)
Showing 20 most recent of 197 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243645 | IC-Flow Imaging System 2.0 | Diagnostic Green GmbH | Sep 22, 2025 | SESE |
| K243077 | Affirm 800 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | Jun 27, 2025 | SESE |
| K231986 | Modus IR | Synaptive Medical, Inc. | Mar 25, 2024 | SESE |
| K234090 | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) | Surgvision GmbH | Mar 20, 2024 | SESE |
| K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) | Carl Zeiss Meditec, Inc. | Jun 20, 2023 | SESE |
| K230727 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc (A Part of Stryker) | Jun 5, 2023 | SESE |
| K222240 | EXPLORER AIR® II | Surgvision GmbH | Feb 28, 2023 | SESE |
| K214097 | Explorer Air II | Surgvision GmbH | Feb 25, 2022 | SESE |
| K202391 | DIR 800 | Aesculap, Inc. | Jan 21, 2021 | SESE |
| K192761 | Asimov-MKS Imaging System | Onlume, Inc. | Jan 17, 2020 | SESE |
| K190772 | SURGICAL MICROSCOPE SYSTEM ORBEYE with IR | Olympus Medical Systems Corp. | Oct 10, 2019 | SESE |
| K182907 | SPY Elite Intraoperative Perfusion Assessment System | Novadaq Technologies Ulc. (Now A Part of Stryker) | Jan 23, 2019 | SESE |
| K181537 | GLOW800 | Leica Microsystems (Schweiz) AG | Sep 7, 2018 | SESE |
| K180019 | CAAS Workstation | Pie Medical Imaging BV | May 3, 2018 | SESE |
| K162991 | YELLOW 560 Fluorescence Module | Carl Zeiss Meditec, AG | Jul 24, 2017 | SESD |
| K170239 | Leica FL560 | Leica Microsystems (Schweiz) AG | Jul 5, 2017 | SEKD |
| K151780 | CAAS Workstation | Pie Medical Imaging BV | Mar 11, 2016 | SESE |
| K141136 | LEICA FL800 | Leica Biosystems Richmond | Aug 19, 2014 | SESE |
| K133719 | PDE-NEO | Hamamatsu Photonics K.K. | Mar 27, 2014 | SESE |
| K133993 | CAAS WORKSTATION | Pie Medical Imaging | Mar 25, 2014 | SESE |
Top Applicants
- Siemens Medical Solutions USA, Inc. — 13 clearances
- Xre Corp. — 10 clearances
- Novadaq Technologies, Inc. — 9 clearances
- GE Medical Systems — 8 clearances
- Shimadzu Medical Systems — 8 clearances
