| OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) (K253459) | ABBOTT MEDICAL | 2026-04-24 |
| LIA Console (542-7) (K251730) | Leadoptik, Inc. | 2025-12-19 |
| HyperVue™ Imaging System - Integrated (K253101) | Spectrawave, Inc. | 2025-12-15 |
| deepLive (OSP12 + DMS) (K252851) | Damae Medical | 2025-10-07 |
| HyperVue™ Software (K251198) | Spectrawave, Inc. | 2025-07-16 |
| OPUSWAVE Dual Sensor Imaging System (K250684) | Terumo Cardiovascular Systems Thi Plant | 2025-07-02 |
| OPXION Optical Skin Viewer (OPXSV1-01F) (K242924) | Opxion Technology, Inc. | 2025-06-23 |
| Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) (K242098) | Shenzhen Vivolight Medical Device & Technology Co., Ltd. | 2025-04-11 |
| Starlight Imaging Catheter (K243016) | Spectrawave, Inc. | 2025-03-20 |
| HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) (K242239) | Gentuity, LLC | 2024-08-16 |
| deepLive (K240610) | Damae Medical | 2024-07-09 |
| ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6 (K232386) | ABBOTT MEDICAL | 2023-09-08 |
| HyperVue™ Imaging System (K230691) | Spectrawave, Inc. | 2023-06-07 |
| SpectraWAVE Imaging System (K221257) | Spectrawave, Inc. | 2023-02-28 |
| OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System (K210458) | ABBOTT MEDICAL | 2021-06-08 |
| OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System (K203578) | Perimeter Medical Imaging Ai, Inc. | 2021-02-25 |
| ApolloVue S100 Image System (K201552) | Apollo Medical Optics, Ltd. | 2020-09-02 |
| Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter (K192922) | Gentuity, LLC | 2020-02-20 |
| NvisionVLE Low-profile Optical Probe (K191117) | Ninepoint Medical, Inc. | 2019-07-19 |
| Ilumien Optis, Optis Integrated, Optis Mobile (K183320) | St. Jude Medical (Now Abbott Medical) | 2019-04-02 |
| OTIS Optical Coherence Tomography SYstem (K190404) | Perimeter Medical Imaging, Inc. | 2019-03-26 |
| NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System (K182616) | Ninepoint Medical, Inc. | 2018-11-02 |
| NvisionVLE Imaging System, NvisionVLE Optical Probe (K182261) | Ninepoint Medical, Inc. | 2018-10-16 |
| OTIS Optical Coherence Tomography System (K171560) | Perimeter Medical Imaging, Inc. | 2017-08-25 |
| LuminScan (TM) Imaging System (K162466) | Micro-Tech (Nanjing) Co., Ltd. | 2016-11-29 |
| VivoSight Dx Topical OCT System (K153283) | Michelson Diagnostics, Ltd. | 2016-08-11 |
| OPTIS Metallic Stent Optimization E.4 SW (K160878) | Lightlab Imaging, Inc. | 2016-06-29 |
| Perimeter Otis™ 1.0 Optical Coherence Tomography System (K160240) | Perimeter Medical Imaging, Inc. | 2016-05-13 |
| NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System (K153479) | Ninepoint Medical, Inc. | 2016-02-16 |
| OPTIS Mobile System (K152120) | Lightlab Imaging, Inc. | 2015-10-29 |
| OPTIS Integrated System Mobile Workstation (K151286) | Lightlab Imaging, Inc. | 2015-08-05 |
| ILUMIEN OPTIS (K150878) | Lightlab Imaging, Inc. | 2015-07-15 |
| ILUMIEN, Drageonfly OPTIS Imaging Catheter (K150237) | Lightlab Imaging, Inc. | 2015-05-05 |
| NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory (K143678) | Ninepoint Medical, Inc. | 2015-02-06 |
| FORESEE (4C) IMAGING SYSTEM (K133209) | Diagnostic Photonics, Inc. | 2014-03-17 |
| SKINTELL (K132800) | Agfa Healthcare N.V. | 2014-03-03 |
| NVISION VLE IMAGING SYSTEM (K120800) | Ninepoint Medical, Inc. | 2013-04-25 |
| ILUMIEN OPTIS (K123369) | Lightlab Imaging, Inc. | 2013-01-30 |
| NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER (K121195) | Ninepoint Medical, Inc. | 2012-07-25 |
| NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER (K112770) | Ninepoint Medical, Inc. | 2011-12-16 |
| C7 XR IMAGING SYSTEM (K111201) | Lightlab Imaging, Inc. | 2011-08-10 |
| TOMOPHASE OCTIS (K102599) | Tomophase Corporation | 2010-12-01 |
| C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES (K093857) | Lightlab Imaging, Inc. | 2010-04-30 |
| VIVOSIGHT TOPICAL OCT SYSTEM (K093520) | Michelson Diagnostics, Ltd. | 2010-01-05 |
| IMALUX NIRIS IMAGING SYSTEM (K042894) | Imalux Corporation | 2004-11-19 |
| IMALUX OCT IMAGING SYSTEM (K033783) | Imalux Coporation | 2004-03-01 |