Product code NQQ
- Device name
- System, Imaging, Optical Coherence Tomography (Oct)
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1560
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| K242924 | OPXION Optical Skin Viewer (OPXSV1-01F) | Opxion Technology, Inc. | 2025-06-23 |
| 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 |
| K201552 | ApolloVue S100 Image System | Apollo Medical Optics, Ltd. | 2020-09-02 |
| K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter | Gentuity, LLC | 2020-02-20 |
| K191117 | NvisionVLE Low-profile Optical Probe | Ninepoint Medical, Inc. | 2019-07-19 |
| K183320 | Ilumien Optis, Optis Integrated, Optis Mobile | St. Jude Medical (Now Abbott Medical) | 2019-04-02 |
| K190404 | OTIS Optical Coherence Tomography SYstem | Perimeter Medical Imaging, Inc. | 2019-03-26 |
| K182616 | NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System | Ninepoint Medical, Inc. | 2018-11-02 |
| K182261 | NvisionVLE Imaging System, NvisionVLE Optical Probe | Ninepoint Medical, Inc. | 2018-10-16 |
| K171560 | OTIS Optical Coherence Tomography System | Perimeter Medical Imaging, Inc. | 2017-08-25 |
| K162466 | LuminScan (TM) Imaging System | Micro-Tech (Nanjing) Co., Ltd. | 2016-11-29 |
| K153283 | VivoSight Dx Topical OCT System | Michelson Diagnostics, Ltd. | 2016-08-11 |
| K160878 | OPTIS Metallic Stent Optimization E.4 SW | Lightlab Imaging, Inc. | 2016-06-29 |
| K160240 | Perimeter Otis™ 1.0 Optical Coherence Tomography System | Perimeter Medical Imaging, Inc. | 2016-05-13 |
| 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 |
| K152120 | OPTIS Mobile System | Lightlab Imaging, Inc. | 2015-10-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00199874783659 | LIA Console | LEADOPTIK INC. | 2026-06-01 |
| 05415067054920 | Ultreon™ | LIGHTLAB IMAGING, INC. | 2026-05-19 |
| 00812763011007 | OPUSWAVE | Terumo Cardiovascular Systems Corporation | 2026-05-13 |
| 06975417183889 | Pantheris | Zylox-Tonbridge Medical Technology Co., Ltd. | 2026-03-21 |
| 06975417183872 | Pantheris | Zylox-Tonbridge Medical Technology Co., Ltd. | 2026-03-21 |
| 06975417183865 | Pantheris | Zylox-Tonbridge Medical Technology Co., Ltd. | 2026-03-21 |
| 06975417183858 | Pantheris | Zylox-Tonbridge Medical Technology Co., Ltd. | 2026-03-21 |
| 06971141530500 | Cornaris Intravascular Imaging System | Shenzhen Vivolight Medical Device & Technology Co., Ltd. | 2025-09-28 |
| 06971141530494 | Cornaris Intravascular Imaging System | Shenzhen Vivolight Medical Device & Technology Co., Ltd. | 2025-09-28 |
| 06932503570046 | Luminscan(TM) Disposable Imaging Kit | Micro-Tech (Nanjing) Co., Ltd. | 2023-08-11 |
| 06932503570022 | Luminscan(TM) Disposable Imaging Kit | Micro-Tech (Nanjing) Co., Ltd. | 2023-08-11 |
| 06932503570053 | Luminscan(TM) Disposable Imaging Kit | Micro-Tech (Nanjing) Co., Ltd. | 2023-08-11 |
| 06932503570060 | Luminscan(TM) Disposable Imaging Kit | Micro-Tech (Nanjing) Co., Ltd. | 2023-08-11 |
| 06932503570077 | Luminscan(TM) Disposable Imaging Kit | Micro-Tech (Nanjing) Co., Ltd. | 2023-08-11 |
| 06932503570084 | Luminscan(TM) Disposable Imaging Kit | Micro-Tech (Nanjing) Co., Ltd. | 2023-08-11 |
| 06932503570091 | Luminscan(TM) Disposable Imaging Kit | Micro-Tech (Nanjing) Co., Ltd. | 2023-08-11 |
| 06932503570107 | Luminscan(TM) Disposable Imaging Kit | Micro-Tech (Nanjing) Co., Ltd. | 2023-08-11 |
| 06932503570039 | Luminscan(TM) Disposable Imaging Kit | Micro-Tech (Nanjing) Co., Ltd. | 2023-08-11 |
| 00851354004554 | Tigereye ST | AVINGER, INC. | 2023-07-24 |
| 00628055603115 | Novasight Hybrid™ Catheter | Conavi Medical Inc | 2023-04-17 |
| 00851354004493 | Tigereye | AVINGER, INC. | 2023-03-14 |
| 00628055603092 | Novasight Hybrid™ PIM | Conavi Medical Inc | 2022-10-25 |
| 00754016215025 | Specimen Immobilizer | Perimeter Medical Imaging AI, Inc. | 2021-08-30 |
| 00041520113429 | Care One | Ahold U.S.A., Inc. | 2021-08-26 |
| 00628055603108 | Novasight Hybrid™ Catheter PIM Bag | Conavi Medical Inc | 2020-09-11 |
| 00628055603085 | Novasight Hybrid™ PIM | Conavi Medical Inc | 2020-09-11 |
| 00628055603078 | Novasight Hybrid™ Hummingbird Console | Conavi Medical Inc | 2020-09-11 |
| 00628055603061 | Novasight Hybrid™ Catheter Accessories Package | Conavi Medical Inc | 2020-09-11 |
| 00628055603054 | Novasight Hybrid™ Catheter | Conavi Medical Inc | 2020-09-09 |
| 05415067030108 | AptiVue™ | ST. JUDE MEDICAL, INC. | 2019-04-30 |