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 Ninepoint Medical, Inc., Lightlab Imaging, Inc. and Spectrawave, Inc..

46
Total
46
Cleared
117d
Avg days
2004
Since
46 devices
25–46 of 46
Cleared Nov 29, 2016
LuminScan (TM) Imaging System
K162466
Micro-Tech (Nanjing) Co., Ltd.
General & Plastic Surgery · 88d
Cleared Aug 11, 2016
VivoSight Dx Topical OCT System
K153283
Michelson Diagnostics, Ltd.
General & Plastic Surgery · 273d
Cleared Jun 29, 2016
OPTIS Metallic Stent Optimization E.4 SW
K160878
Lightlab Imaging, Inc.
General & Plastic Surgery · 91d
Cleared May 13, 2016
Perimeter Otis™ 1.0 Optical Coherence Tomography System
K160240
Perimeter Medical Imaging, Inc.
General & Plastic Surgery · 102d
Cleared Feb 16, 2016
NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
K153479
Ninepoint Medical, Inc.
General & Plastic Surgery · 76d
Cleared Oct 29, 2015
OPTIS Mobile System
K152120
Lightlab Imaging, Inc.
General & Plastic Surgery · 91d
Cleared Aug 05, 2015
OPTIS Integrated System Mobile Workstation
K151286
Lightlab Imaging, Inc.
General & Plastic Surgery · 83d
Cleared Jul 15, 2015
ILUMIEN OPTIS
K150878
Lightlab Imaging, Inc.
General & Plastic Surgery · 105d
Cleared May 05, 2015
ILUMIEN, Drageonfly OPTIS Imaging Catheter
K150237
Lightlab Imaging, Inc.
General & Plastic Surgery · 92d
Cleared Feb 06, 2015
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
K143678
Ninepoint Medical, Inc.
General & Plastic Surgery · 44d
Cleared Mar 17, 2014
FORESEE (4C) IMAGING SYSTEM
K133209
Diagnostic Photonics, Inc.
General & Plastic Surgery · 151d
Cleared Mar 03, 2014
SKINTELL
K132800
Agfa Healthcare N.V.
General & Plastic Surgery · 178d
Cleared Apr 25, 2013
NVISION VLE IMAGING SYSTEM
K120800
Ninepoint Medical, Inc.
General & Plastic Surgery · 405d
Cleared Jan 30, 2013
ILUMIEN OPTIS
K123369
Lightlab Imaging, Inc.
General & Plastic Surgery · 90d
Cleared Jul 25, 2012
NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
K121195
Ninepoint Medical, Inc.
General & Plastic Surgery · 97d
Cleared Dec 16, 2011
NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER
K112770
Ninepoint Medical, Inc.
General & Plastic Surgery · 84d
Cleared Aug 10, 2011
C7 XR IMAGING SYSTEM
K111201
Lightlab Imaging, Inc.
General & Plastic Surgery · 103d
Cleared Nov 19, 2004
IMALUX NIRIS IMAGING SYSTEM
K042894
Imalux Corporation
General & Plastic Surgery · 30d