AI devices with FDA product code NQQ — System, Imaging, Optical Coherence Tomography (Oct)
Product code NQQ (“System, Imaging, Optical Coherence Tomography (Oct)” in openFDA) covers 4 devices on the FDA AI-enabled list, from 4 companies. Most are reviewed by the Radiology panel (4). The most recent decision was OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) on April 24, 2026.
4AI devices
3Companies
2018First decision
2026-04-24Latest decision
Trend: devices per year
201820212026
Top companies
All 4 devices, newest first
- OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)ABBOTT MEDICAL · Radiology
- OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging SystemAbbott Medical · Radiology
- OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography SystemPerimeter Medical Imaging AI, Inc. · Radiology
- NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinePoint Medical, Inc. · Radiology