Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1600](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1600) → IZI — System, X-Ray, Angiographic # IZI · System, X-Ray, Angiographic _Radiology · 21 CFR 892.1600 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI ## Overview - **Product Code:** IZI - **Device Name:** System, X-Ray, Angiographic - **Regulation:** [21 CFR 892.1600](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1600) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) ## 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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K243645.md) | IC-Flow™ Imaging System 2.0 | Diagnostic Green GmbH | Sep 22, 2025 | SESE | | [K243077](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K243077.md) | Affirm 800 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | Jun 27, 2025 | SESE | | [K231986](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K231986.md) | Modus IR | Synaptive Medical, Inc. | Mar 25, 2024 | SESE | | [K234090](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K234090.md) | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) | Surgvision GmbH | Mar 20, 2024 | SESE | | [K231075](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K231075.md) | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) | Carl Zeiss Meditec, Inc. | Jun 20, 2023 | SESE | | [K230727](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K230727.md) | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc (A Part of Stryker) | Jun 5, 2023 | SESE | | [K222240](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K222240.md) | EXPLORER AIR® II | Surgvision GmbH | Feb 28, 2023 | SESE | | [K214097](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K214097.md) | Explorer Air II | Surgvision GmbH | Feb 25, 2022 | SESE | | [K202391](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K202391.md) | DIR 800 | Aesculap, Inc. | Jan 21, 2021 | SESE | | [K192761](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K192761.md) | Asimov-MKS Imaging System | Onlume, Inc. | Jan 17, 2020 | SESE | | [K190772](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K190772.md) | SURGICAL MICROSCOPE SYSTEM ORBEYE with IR | Olympus Medical Systems Corp. | Oct 10, 2019 | SESE | | [K182907](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K182907.md) | SPY Elite Intraoperative Perfusion Assessment System | Novadaq Technologies Ulc. (Now A Part of Stryker) | Jan 23, 2019 | SESE | | [K181537](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K181537.md) | GLOW800 | Leica Microsystems (Schweiz) AG | Sep 7, 2018 | SESE | | [K180019](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K180019.md) | CAAS Workstation | Pie Medical Imaging BV | May 3, 2018 | SESE | | [K162991](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K162991.md) | YELLOW 560 Fluorescence Module | Carl Zeiss Meditec, AG | Jul 24, 2017 | SESD | | [K170239](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K170239.md) | Leica FL560 | Leica Microsystems (Schweiz) AG | Jul 5, 2017 | SEKD | | [K151780](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K151780.md) | CAAS Workstation | Pie Medical Imaging BV | Mar 11, 2016 | SESE | | [K141136](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K141136.md) | LEICA FL800 | Leica Biosystems Richmond | Aug 19, 2014 | SESE | | [K133719](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K133719.md) | PDE-NEO | Hamamatsu Photonics K.K. | Mar 27, 2014 | SESE | | [K133993](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI/K133993.md) | 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 - Shimadzu Precision Instruments, Inc. — 8 clearances - Shimadzu Medical Systems — 8 clearances --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com