NQQ — System, Imaging, Optical Coherence Tomography (Oct) Class II
Classification Details
- Product Code
- NQQ
- Device Class
- Class II
- Regulation Number
- 892.1560
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Radiology
- Implant
- No
Definition
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251730 | leadoptik | LIA Console (542-7) | December 19, 2025 |
| K253101 | spectrawave | HyperVue Imaging System - Integrated | December 15, 2025 |
| K252851 | damae medical | deepLive (OSP12 + DMS) | October 7, 2025 |
| K251198 | spectrawave | HyperVue Software | July 16, 2025 |
| K250684 | terumo cardiovascular systems thi plant | OPUSWAVE Dual Sensor Imaging System | July 2, 2025 |
| K242924 | opxion technology | OPXION Optical Skin Viewer (OPXSV1-01F) | June 23, 2025 |
| K242098 | shenzhen vivolight medical device and technology co | Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging Sy | April 11, 2025 |
| K243016 | spectrawave | Starlight Imaging Catheter | March 20, 2025 |
| K242239 | gentuity | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), | August 16, 2024 |
| K240610 | damae medical | deepLive | July 9, 2024 |
| K232386 | abbott medical | ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with Apt | September 8, 2023 |
| K230691 | spectrawave | HyperVue Imaging System | June 7, 2023 |
| K221257 | spectrawave | SpectraWAVE Imaging System | February 28, 2023 |
| K210458 | abbott medical | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System | June 8, 2021 |
| K203578 | perimeter medical imaging ai | OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography | February 25, 2021 |
| K201552 | apollo medical optics | ApolloVue S100 Image System | September 2, 2020 |
| K192922 | gentuity | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter | February 20, 2020 |
| K191117 | ninepoint medical | NvisionVLE Low-profile Optical Probe | July 19, 2019 |
| K183320 | st. jude medical (now abbott medical) | Ilumien Optis, Optis Integrated, Optis Mobile | April 2, 2019 |
| K190404 | perimeter medical imaging | OTIS Optical Coherence Tomography SYstem | March 26, 2019 |