NQQ · Class II · 21 CFR 892.1560

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.

2
Total
2
Cleared
71d
Avg days
2021
Since

List of System, Imaging, Optical Coherence Tomography (oct) devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Sep 08, 2023
ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6
K232386
Abbott Medical
Cardiovascular · 30d
Cleared Jun 08, 2021
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
K210458
Abbott Medical
Cardiovascular · 112d

How to use this database

This page lists all FDA 510(k) submissions for System, Imaging, Optical Coherence Tomography (oct) devices (product code NQQ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →