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| K251730 | LIA Console (542-7) | Leadoptik, Inc. | 2025-12-19 |
| K253101 | HyperVue Imaging System - Integrated | Spectrawave, Inc. | 2025-12-15 |
| K252851 | deepLive (OSP12 + DMS) | Damae Medical | 2025-10-07 |
| K251198 | HyperVue Software | Spectrawave, Inc. | 2025-07-16 |
| K250684 | OPUSWAVE Dual Sensor Imaging System | Terumo Cardiovascular Systems Thi Plant | 2025-07-02 |
| K242098 | Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) | Shenzhen Vivolight Medical Device & Technology Co., Ltd. | 2025-04-11 |
| K243016 | Starlight Imaging Catheter | Spectrawave, Inc. | 2025-03-20 |
| K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) | Gentuity, LLC | 2024-08-16 |
| K240610 | deepLive | Damae Medical | 2024-07-09 |
| K232386 | ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6 | ABBOTT MEDICAL | 2023-09-08 |
| K230691 | HyperVue Imaging System | Spectrawave, Inc. | 2023-06-07 |
| K221257 | SpectraWAVE Imaging System | Spectrawave, Inc. | 2023-02-28 |
| K210458 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System | ABBOTT MEDICAL | 2021-06-08 |
| K203578 | OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System | Perimeter Medical Imaging Ai, Inc. | 2021-02-25 |