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 Spectrawave, Inc., Ninepoint Medical, Inc. and Abbott Medical.
46
Total
46
Cleared
117d
Avg days
2004
Since
Growing category -
11 submissions in the last 2 years
vs 3 in the prior period
Review times increasing: avg
143d
recently vs 108d historically
FDA 510(k) Cleared System, Imaging, Optical Coherence Tomography (oct) Devices (Product Code NQQ)
46 devices
Cleared
Apr 24, 2026
OPTIS Mobile Next Imaging System (1014932)
Abbott Medical
Cardiovascular
199d
Cleared
Dec 19, 2025
LIA Console (542-7)
Leadoptik, Inc.
General & Plastic Surgery
196d
Cleared
Dec 15, 2025
HyperVue™ Imaging System - Integrated
Spectrawave, Inc.
Cardiovascular
82d
Cleared
Oct 07, 2025
deepLive (OSP12 + DMS)
Damae Medical
General & Plastic Surgery
29d
Cleared
Jul 16, 2025
HyperVue™ Software
Spectrawave, Inc.
Cardiovascular
90d
Cleared
Jul 02, 2025
OPUSWAVE Dual Sensor Imaging System
Terumo Cardiovascular Systems Thi Plant
Cardiovascular
118d
Cleared
Jun 23, 2025
OPXION Optical Skin Viewer (OPXSV1-01F)
Opxion Technology, Inc.
General & Plastic Surgery
272d
Cleared
Apr 11, 2025
Cornaris Intravascular Imaging System (P80-E)
Shenzhen Vivolight Medical Device & Technology Co., Ltd.
Cardiovascular
267d
Cleared
Mar 20, 2025
Starlight Imaging Catheter
Spectrawave, Inc.
Cardiovascular
174d
Cleared
Aug 16, 2024
HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))
Gentuity, LLC
Cardiovascular
17d
Cleared
Jul 09, 2024
deepLive
Damae Medical
General & Plastic Surgery
126d
Cleared
Sep 08, 2023
ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6
Abbott Medical
Cardiovascular
30d
Cleared
Jun 07, 2023
HyperVue™ Imaging System
Spectrawave, Inc.
Cardiovascular
86d
Cleared
Feb 28, 2023
SpectraWAVE Imaging System
Spectrawave, Inc.
Cardiovascular
302d
Cleared
Jun 08, 2021
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
Abbott Medical
Cardiovascular
112d
Cleared
Feb 25, 2021
OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
Perimeter Medical Imaging Ai, Inc.
General & Plastic Surgery
80d
Cleared
Sep 02, 2020
ApolloVue S100 Image System
Apollo Medical Optics, Ltd.
General & Plastic Surgery
84d
Cleared
Feb 20, 2020
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
Gentuity, LLC
Cardiovascular
127d
Cleared
Jul 19, 2019
NvisionVLE Low-profile Optical Probe
Ninepoint Medical, Inc.
General & Plastic Surgery
84d
Cleared
Apr 02, 2019
Ilumien Optis, Optis Integrated, Optis Mobile
St. Jude Medical (Now Abbott Medical)
Cardiovascular
123d
Cleared
Mar 26, 2019
OTIS Optical Coherence Tomography SYstem
Perimeter Medical Imaging, Inc.
General & Plastic Surgery
35d
Cleared
Nov 02, 2018
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
Ninepoint Medical, Inc.
General & Plastic Surgery
42d
Cleared
Oct 16, 2018
NvisionVLE Imaging System, NvisionVLE Optical Probe
Ninepoint Medical, Inc.
General & Plastic Surgery
56d
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 510(k) Review Time - NQQ Product Code
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 →