4 devices · 4 companies · 2018 to 2026
Product code NQQ: System, Imaging, Optical Coherence Tomography (Oct)
4 devices under product code NQQ, 2018 to 2026, from 4 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (4 of 4 here), the regulation, and MAUDE report counts by product code.
System, Imaging, Optical Coherence Tomography (Oct). 21 CFR 892.1560, Class II. This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging. MAUDE held 69 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| OPTIS Mobile Next Imaging SystemK253459 · 510(k) | ABBOTT MEDICAL | Radiology | database entry | |
| OPTIS Mobile Next Imaging System, OPTIS IntegratK210458 · 510(k) | Abbott Medical | Radiology | database entry | |
| OTIS 2.1 Optical Coherence Tomography System, THK203578 · 510(k) | Perimeter Medical Imaging AI, Inc. | Radiology | database entry | |
| NvisionVLE Imaging System, NvisionVLE Optical PrK182616 · 510(k) | NinePoint Medical, Inc. | Radiology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.