FDA Product Code
FDA Product Code NQQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1560
510(k) Clearances — 46 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) | ABBOTT MEDICAL | 2026-04-24 | Traditional | PDF ↗ |
| K251730 | LIA Console (542-7) | Leadoptik, Inc. | 2025-12-19 | Traditional | PDF ↗ |
| K253101 | HyperVue Imaging System - Integrated | Spectrawave, Inc. | 2025-12-15 | Traditional | PDF ↗ |
| K252851 | deepLive (OSP12 + DMS) | Damae Medical | 2025-10-07 | Special | PDF ↗ |
| K251198 | HyperVue Software | Spectrawave, Inc. | 2025-07-16 | Traditional | PDF ↗ |
| K250684 | OPUSWAVE Dual Sensor Imaging System | Terumo Cardiovascular Systems Thi Plant | 2025-07-02 | Traditional | PDF ↗ |
| K242924 | OPXION Optical Skin Viewer (OPXSV1-01F) | Opxion Technology, Inc. | 2025-06-23 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K243016 | Starlight Imaging Catheter | Spectrawave, Inc. | 2025-03-20 | Special | PDF ↗ |
| 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 | Special | PDF ↗ |
| K240610 | deepLive | Damae Medical | 2024-07-09 | Traditional | PDF ↗ |
| K232386 | ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6 | ABBOTT MEDICAL | 2023-09-08 | Special | PDF ↗ |
| K230691 | HyperVue Imaging System | Spectrawave, Inc. | 2023-06-07 | Traditional | PDF ↗ |
| K221257 | SpectraWAVE Imaging System | Spectrawave, Inc. | 2023-02-28 | Traditional | PDF ↗ |
| K210458 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System | ABBOTT MEDICAL | 2021-06-08 | Traditional | PDF ↗ |
| K203578 | OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System | Perimeter Medical Imaging Ai, Inc. | 2021-02-25 | Special | PDF ↗ |
| K201552 | ApolloVue S100 Image System | Apollo Medical Optics, Ltd. | 2020-09-02 | Traditional | PDF ↗ |
| K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter | Gentuity, LLC | 2020-02-20 | Traditional | PDF ↗ |
| K191117 | NvisionVLE Low-profile Optical Probe | Ninepoint Medical, Inc. | 2019-07-19 | Traditional | PDF ↗ |
| K183320 | Ilumien Optis, Optis Integrated, Optis Mobile | St. Jude Medical (Now Abbott Medical) | 2019-04-02 | Traditional | PDF ↗ |
| K190404 | OTIS Optical Coherence Tomography SYstem | Perimeter Medical Imaging, Inc. | 2019-03-26 | Traditional | PDF ↗ |
| K182616 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System | Ninepoint Medical, Inc. | 2018-11-02 | Traditional | PDF ↗ |
| K182261 | NvisionVLE Imaging System, NvisionVLE Optical Probe | Ninepoint Medical, Inc. | 2018-10-16 | Special | PDF ↗ |
| K171560 | OTIS Optical Coherence Tomography System | Perimeter Medical Imaging, Inc. | 2017-08-25 | Traditional | PDF ↗ |
| K162466 | LuminScan (TM) Imaging System | Micro-Tech (Nanjing) Co., Ltd. | 2016-11-29 | Traditional | PDF ↗ |
| K153283 | VivoSight Dx Topical OCT System | Michelson Diagnostics, Ltd. | 2016-08-11 | Traditional | PDF ↗ |
| K160878 | OPTIS Metallic Stent Optimization E.4 SW | Lightlab Imaging, Inc. | 2016-06-29 | Traditional | PDF ↗ |
| K160240 | Perimeter Otis 1.0 Optical Coherence Tomography System | Perimeter Medical Imaging, Inc. | 2016-05-13 | Traditional | PDF ↗ |
| K153479 | NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System | Ninepoint Medical, Inc. | 2016-02-16 | Traditional | PDF ↗ |
| K152120 | OPTIS Mobile System | Lightlab Imaging, Inc. | 2015-10-29 | Traditional | PDF ↗ |
| K151286 | OPTIS Integrated System Mobile Workstation | Lightlab Imaging, Inc. | 2015-08-05 | Traditional | PDF ↗ |
| K150878 | ILUMIEN OPTIS | Lightlab Imaging, Inc. | 2015-07-15 | Traditional | PDF ↗ |
| K150237 | ILUMIEN, Drageonfly OPTIS Imaging Catheter | Lightlab Imaging, Inc. | 2015-05-05 | Traditional | PDF ↗ |
| K143678 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory | Ninepoint Medical, Inc. | 2015-02-06 | Special | PDF ↗ |
| K133209 | FORESEE (4C) IMAGING SYSTEM | Diagnostic Photonics, Inc. | 2014-03-17 | Traditional | PDF ↗ |
| K132800 | SKINTELL | Agfa Healthcare N.V. | 2014-03-03 | Traditional | PDF ↗ |
| K120800 | NVISION VLE IMAGING SYSTEM | Ninepoint Medical, Inc. | 2013-04-25 | Traditional | PDF ↗ |
| K123369 | ILUMIEN OPTIS | Lightlab Imaging, Inc. | 2013-01-30 | Traditional | PDF ↗ |
| K121195 | NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER | Ninepoint Medical, Inc. | 2012-07-25 | Special | PDF ↗ |
| K112770 | NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER | Ninepoint Medical, Inc. | 2011-12-16 | Traditional | PDF ↗ |
| K111201 | C7 XR IMAGING SYSTEM | Lightlab Imaging, Inc. | 2011-08-10 | Traditional | PDF ↗ |
| K102599 | TOMOPHASE OCTIS | Tomophase Corporation | 2010-12-01 | Traditional | PDF ↗ |
| K093857 | C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES | Lightlab Imaging, Inc. | 2010-04-30 | Traditional | PDF ↗ |
| K093520 | VIVOSIGHT TOPICAL OCT SYSTEM | Michelson Diagnostics, Ltd. | 2010-01-05 | Traditional | PDF ↗ |
| K042894 | IMALUX NIRIS IMAGING SYSTEM | Imalux Corporation | 2004-11-19 | Special | PDF ↗ |
| K033783 | IMALUX OCT IMAGING SYSTEM | Imalux Coporation | 2004-03-01 | Traditional | PDF ↗ |
Product code NQQ · Class II · Radiology. Data: openFDA.