FDA Product Code NQQ: System, Imaging, Optical Coherence Tomography (oct)
This Device Uses Back-reflected Light To Create Two-dimensional Images Versus Back-reflected Sound Waves As Are Used In Ultrasound Imaging.
Leading manufacturers include Abbott Medical, Spectrawave, Inc. and Damae Medical.
FDA 510(k) Cleared System, Imaging, Optical Coherence Tomography (oct) Devices (Product Code NQQ)
About Product Code NQQ - Regulatory Context
510(k) Submission Activity
46 total 510(k) submissions under product code NQQ since 2004, with 46 receiving FDA clearance (average review time: 117 days).
Submission volume has increased in recent years - 11 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under NQQ have taken an average of 143 days to reach a decision - up from 108 days historically. Manufacturers should account for longer review timelines in current project planning.
NQQ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →