NQQ — System, Imaging, Optical Coherence Tomography (Oct) Class II
FDA product code NQQ covers "System, Imaging, Optical Coherence Tomography (Oct)", a Class II medical device regulated under 21 CFR 892.1560. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253459 | abbott medical | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System | April 24, 2026 |
| 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 |