NQQ
- Product code
- NQQ
- Device name
- System, Imaging, Optical Coherence Tomography (Oct)
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.1560
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 11
- Summaries archived here
- 10 (direct download)
- 510(k) clearances (all years, FDA)
- 46 (all years; only the last 3 years are listed here)
FDA classification definition
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
510(k) clearances, last 3 years (11)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253459 | 2026-04-24 | ABBOTT MEDICAL | OPTIS Mobile Next Imaging System (1014932); OPTIS In | |
| K251730 | 2025-12-19 | Leadoptik, Inc. | LIA Console (542-7) | |
| K253101 | 2025-12-15 | Spectrawave, Inc. | HyperVue Imaging System - Integrated | |
| K252851 | 2025-10-07 | Damae Medical | deepLive (OSP12 + DMS) | |
| K251198 | 2025-07-16 | Spectrawave, Inc. | HyperVue Software | |
| K250684 | 2025-07-02 | Terumo Cardiovascular Systems Thi Plan | OPUSWAVE Dual Sensor Imaging System | |
| K242924 | 2025-06-23 | Opxion Technology, Inc. | OPXION Optical Skin Viewer (OPXSV1-01F) | |
| K242098 | 2025-04-11 | Shenzhen Vivolight Medical Device & Te | Cornaris Intravascular Imaging System (P80-E); Corna | |
| K243016 | 2025-03-20 | Spectrawave, Inc. | Starlight Imaging Catheter | FDA |
| K242239 | 2024-08-16 | Gentuity, LLC | HF-OCT Imaging System with Vis-RX Micro-Imaging Cath | |
| K240610 | 2024-07-09 | Damae Medical | deepLive |
Official FDA classification page: NQQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).