System, Imaging, Optical Coherence Tomography (Oct)
Regulation 892.1560
3510(k)s in 12 months (46 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in NQQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Ninepoint Medical, Inc. | 8 | 1 |
| Lightlab Imaging, Inc. | 8 | 0 |
| Spectrawave, Inc. | 5 | 0 |
| ABBOTT MEDICAL | 3 | 0 |
| Perimeter Medical Imaging, Inc. | 3 | 0 |
| Damae Medical | 2 | 0 |
| Gentuity, LLC | 2 | 0 |
| Imalux Corporation | 1 | 1 |
| Michelson Diagnostics, Ltd. | 2 | 0 |
| Agfa Healthcare N.V. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 24, 2026 | K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade ABBOTT MEDICAL | NQQ |
| Dec 19, 2025 | K251730 | LIA Console (542-7) Leadoptik, Inc. | NQQ |
| Dec 15, 2025 | K253101 | HyperVue Imaging System - Integrated Spectrawave, Inc. | NQQ |
| Oct 7, 2025 | K252851 | deepLive (OSP12 + DMS) Damae Medical, FR | NQQ |
| Jul 16, 2025 | K251198 | HyperVue Software Spectrawave, Inc. | NQQ |
| Jul 2, 2025 | K250684 | OPUSWAVE Dual Sensor Imaging System Terumo Cardiovascular Systems Thi Plant | NQQ |
| Jun 23, 2025 | K242924 | OPXION Optical Skin Viewer (OPXSV1-01F) Opxion Technology, Inc., TW | NQQ |
| Apr 11, 2025 | K242098 | Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Cath Shenzhen Vivolight Medical Device & Technology Co., Ltd., CN | NQQ |
| Mar 20, 2025 | K243016 | Starlight Imaging Catheter Spectrawave, Inc. | NQQ |
| Aug 16, 2024 | K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) Gentuity, LLC | NQQ |
| Jul 9, 2024 | K240610 | deepLive Damae Medical, FR | NQQ |
| Sep 8, 2023 | K232386 | ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6 ABBOTT MEDICAL | NQQ |
| Jun 7, 2023 | K230691 | HyperVue Imaging System Spectrawave, Inc. | NQQ |
| Feb 28, 2023 | K221257 | SpectraWAVE Imaging System Spectrawave, Inc. | NQQ |
| Jun 8, 2021 | K210458 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System ABBOTT MEDICAL | NQQ |
| Feb 25, 2021 | K203578 | OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System Perimeter Medical Imaging Ai, Inc., CA | NQQ |
| Sep 2, 2020 | K201552 | ApolloVue S100 Image System Apollo Medical Optics, Ltd., TW | NQQ |
| Feb 20, 2020 | K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter Gentuity, LLC | NQQ |
| Jul 19, 2019 | K191117 | NvisionVLE Low-profile Optical Probe Ninepoint Medical, Inc. | NQQ |
| Apr 2, 2019 | K183320 | Ilumien Optis, Optis Integrated, Optis Mobile St. Jude Medical (Now Abbott Medical) | NQQ |
| Mar 26, 2019 | K190404 | OTIS Optical Coherence Tomography SYstem Perimeter Medical Imaging, Inc., CA | NQQ |
| Nov 2, 2018 | K182616 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System Ninepoint Medical, Inc. | NQQ |
| Oct 16, 2018 | K182261 | NvisionVLE Imaging System, NvisionVLE Optical Probe Ninepoint Medical, Inc. | NQQ |
| Aug 25, 2017 | K171560 | OTIS Optical Coherence Tomography System Perimeter Medical Imaging, Inc., CA | NQQ |
| Nov 29, 2016 | K162466 | LuminScan (TM) Imaging System Micro-Tech (Nanjing) Co., Ltd., CN | NQQ |
| Aug 11, 2016 | K153283 | VivoSight Dx Topical OCT System Michelson Diagnostics, Ltd., GB | NQQ |
| Jun 29, 2016 | K160878 | OPTIS Metallic Stent Optimization E.4 SW Lightlab Imaging, Inc. | NQQ |
| May 13, 2016 | K160240 | Perimeter Otis 1.0 Optical Coherence Tomography System Perimeter Medical Imaging, Inc., CA | NQQ |
| Feb 16, 2016 | K153479 | NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Ma Ninepoint Medical, Inc. | NQQ |
| Oct 29, 2015 | K152120 | OPTIS Mobile System Lightlab Imaging, Inc. | NQQ |
| Aug 5, 2015 | K151286 | OPTIS Integrated System Mobile Workstation Lightlab Imaging, Inc. | NQQ |
| Jul 15, 2015 | K150878 | ILUMIEN OPTIS Lightlab Imaging, Inc. | NQQ |
| May 5, 2015 | K150237 | ILUMIEN, Drageonfly OPTIS Imaging Catheter Lightlab Imaging, Inc. | NQQ |
| Feb 6, 2015 | K143678 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory Ninepoint Medical, Inc. | NQQ |
| Mar 17, 2014 | K133209 | FORESEE (4C) IMAGING SYSTEM Diagnostic Photonics, Inc. | NQQ |
| Mar 3, 2014 | K132800 | SKINTELL Agfa Healthcare N.V. | NQQ |
| Apr 25, 2013 | K120800 | NVISION VLE IMAGING SYSTEM Ninepoint Medical, Inc. | NQQ |
| Jan 30, 2013 | K123369 | ILUMIEN OPTIS Lightlab Imaging, Inc. | NQQ |
| Jul 25, 2012 | K121195 | NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER Ninepoint Medical, Inc. | NQQ |
| Dec 16, 2011 | K112770 | NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER Ninepoint Medical, Inc. | NQQ |
| Aug 10, 2011 | K111201 | C7 XR IMAGING SYSTEM Lightlab Imaging, Inc. | NQQ |
| Dec 1, 2010 | K102599 | TOMOPHASE OCTIS Tomophase Corporation | NQQ |
| Apr 30, 2010 | K093857 | C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES Lightlab Imaging, Inc. | NQQ |
| Jan 5, 2010 | K093520 | VIVOSIGHT TOPICAL OCT SYSTEM Michelson Diagnostics, Ltd., GB | NQQ |
| Nov 19, 2004 | K042894 | IMALUX NIRIS IMAGING SYSTEM Imalux Corporation | NQQ |
| Mar 1, 2004 | K033783 | IMALUX OCT IMAGING SYSTEM Imalux Coporation | NQQ |
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