System, Imaging, Optical Coherence Tomography (Oct)
FDA product code NQQ · Class II (moderate risk) · 21 CFR 892.1560 · Radiology
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
46510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Lightlab Imaging, Inc. 8
- Ninepoint Medical, Inc. 8
- Spectrawave, Inc. 5
- Perimeter Medical Imaging, Inc. 3
- Abbott Medical 3
- Michelson Diagnostics, Ltd. 2
- Damae Medical 2
- Gentuity, LLC 2
- St. Jude Medical (Now Abbott Medical) 1
- Leadoptik, Inc. 1
- Terumo Cardiovascular Systems Thi Plant 1
- Opxion Technology, Inc. 1
- Shenzhen Vivolight Medical Device & Technology Co., Ltd. 1
- Perimeter Medical Imaging Ai, Inc. 1
- Apollo Medical Optics, Ltd. 1
- Imalux Coporation 1
- Micro-Tech (Nanjing) Co., Ltd. 1
- Diagnostic Photonics, Inc. 1
- Agfa Healthcare N.V. 1
- Tomophase Corporation 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System…NQQ · Traditional | Abbott Medical | 04/24/2026SE |
| K251730 | LIA Console (542-7)NQQ · Traditional | Leadoptik, Inc. | 12/19/2025SE |
| K253101 | HyperVue Imaging System - IntegratedNQQ · Traditional | Spectrawave, Inc. | 12/15/2025SE |
| K252851 | deepLive (OSP12 + DMS)NQQ · Special | Damae Medical | 10/07/2025SE |
| K251198 | HyperVue SoftwareNQQ · Traditional | Spectrawave, Inc. | 07/16/2025SE |
| K250684 | OPUSWAVE Dual Sensor Imaging SystemNQQ · Traditional | Terumo Cardiovascular Systems Thi Plant | 07/02/2025SE |
| K242924 | OPXION Optical Skin Viewer (OPXSV1-01F)NQQ · Traditional | Opxion Technology, Inc. | 06/23/2025SE |
| K242098 | Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System…NQQ · Traditional | Shenzhen Vivolight Medical Device & Technology… | 04/11/2025SE |
| K243016 | Starlight Imaging CatheterNQQ · Special | Spectrawave, Inc. | 03/20/2025SE |
| K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30…NQQ · Special | Gentuity, LLC | 08/16/2024SE |
| K240610 | deepLiveNQQ · Traditional | Damae Medical | 07/09/2024SE |
| K232386 | ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue…NQQ · Special | Abbott Medical | 09/08/2023SE |
| K230691 | HyperVue Imaging SystemNQQ · Traditional | Spectrawave, Inc. | 06/07/2023SE |
| K221257 | SpectraWAVE Imaging SystemNQQ · Traditional | Spectrawave, Inc. | 02/28/2023SE |
| K210458 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging SystemNQQ · Traditional | Abbott Medical | 06/08/2021SE |
| K203578 | OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography SystemNQQ · Special | Perimeter Medical Imaging Ai, Inc. | 02/25/2021SE |
| K201552 | ApolloVue S100 Image SystemNQQ · Traditional | Apollo Medical Optics, Ltd. | 09/02/2020SE |
| K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging CatheterNQQ · Traditional | Gentuity, LLC | 02/20/2020SE |
| K191117 | NvisionVLE Low-profile Optical ProbeNQQ · Traditional | Ninepoint Medical, Inc. | 07/19/2019SESU |
| K183320 | Ilumien Optis, Optis Integrated, Optis MobileNQQ · Traditional | St. Jude Medical (Now Abbott Medical) | 04/02/2019SE |
| K190404 | OTIS Optical Coherence Tomography SYstemNQQ · Traditional | Perimeter Medical Imaging, Inc. | 03/26/2019SE |
| K182616 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNQQ · Traditional | Ninepoint Medical, Inc. | 11/02/2018SESU |
| K182261 | NvisionVLE Imaging System, NvisionVLE Optical ProbeNQQ · Special | Ninepoint Medical, Inc. | 10/16/2018SESU |
| K171560 | OTIS Optical Coherence Tomography SystemNQQ · Traditional | Perimeter Medical Imaging, Inc. | 08/25/2017SESU |
| K162466 | LuminScan (TM) Imaging SystemNQQ · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 11/29/2016SE |
| K153283 | VivoSight Dx Topical OCT SystemNQQ · Traditional | Michelson Diagnostics, Ltd. | 08/11/2016SE |
| K160878 | OPTIS Metallic Stent Optimization E.4 SWNQQ · Traditional | Lightlab Imaging, Inc. | 06/29/2016SE |
| K160240 | Perimeter Otis 1.0 Optical Coherence Tomography SystemNQQ · Traditional | Perimeter Medical Imaging, Inc. | 05/13/2016SESU |
| K153479 | NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…NQQ · Traditional | Ninepoint Medical, Inc. | 02/16/2016SESU |
| K152120 | OPTIS Mobile SystemNQQ · Traditional | Lightlab Imaging, Inc. | 10/29/2015SE |
| K151286 | OPTIS Integrated System Mobile WorkstationNQQ · Traditional | Lightlab Imaging, Inc. | 08/05/2015SE |
| K150878 | Ilumien OptisNQQ · Traditional | Lightlab Imaging, Inc. | 07/15/2015SE |
| K150237 | ILUMIEN, Drageonfly OPTIS Imaging CatheterNQQ · Traditional | Lightlab Imaging, Inc. | 05/05/2015SE |
| K143678 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryNQQ · Special | Ninepoint Medical, Inc. | 02/06/2015SESU |
| K133209 | Foresee (4C) Imaging SystemNQQ · Traditional | Diagnostic Photonics, Inc. | 03/17/2014SE |
| K132800 | SkintellNQQ · Traditional | Agfa Healthcare N.V. | 03/03/2014SE |
| K120800 | Nvision Vle Imaging SystemNQQ · Traditional | Ninepoint Medical, Inc. | 04/25/2013SESU |
| K123369 | Ilumien OptisNQQ · Traditional | Lightlab Imaging, Inc. | 01/30/2013SE |
| K121195 | Nvision Vle Imaging System Nvision Vle CatheterNQQ · Special | Ninepoint Medical, Inc. | 07/25/2012SE |
| K112770 | Nvision Vle Imaging System, Nvision Vle CatheterNQQ · Traditional | Ninepoint Medical, Inc. | 12/16/2011SE |
| K111201 | C7 XR Imaging SystemNQQ · Traditional | Lightlab Imaging, Inc. | 08/10/2011SE |
| K102599 | Tomophase OctisNQQ · Traditional | Tomophase Corporation | 12/01/2010SE |
| K093857 | C7 XR Imaging System with C7 Dragonfly Imaging Catheter and Disposable AccessoriesNQQ · Traditional | Lightlab Imaging, Inc. | 04/30/2010SE |
| K093520 | Vivosight Topical Oct SystemNQQ · Traditional | Michelson Diagnostics, Ltd. | 01/05/2010SE |
| K042894 | Imalux Niris Imaging SystemNQQ · Special | Imalux Corporation | 11/19/2004SE |
| K033783 | Imalux Oct Imaging SystemNQQ · Traditional | Imalux Coporation | 03/01/2004SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1781-2018 Class II | NvisionVLE Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI…Distal tips of the probes may detach from the probe shaft during use. | Ninepoint Medical Inc. | 04/11/2018Terminated |
| Z-0934-2012 | Imalux Niris OCT Imaging System Probe, Model Number 1300, Serial Number F464019, IMALUX…During an FDA inspection, the firm was notified that the wrong tubing was used during the manufacture of the… | Imalux Corporation | 12/22/2011Terminated |
| Z-1004-2011 | Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging…Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient. | Optovue Inc. | 07/20/2010Terminated |