System, Imaging, Optical Coherence Tomography (Oct)

FDA product code NQQ · 39 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.1560
Review panel: SU
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 2004-03-01 – 2026-04-24

This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.

NQQ 2026-04-24

OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)

Applicant ABBOTT MEDICAL

K number K253459

View details →

NQQ 2025-12-19

LIA Console (542-7)

Applicant Leadoptik, Inc.

K number K251730

View details →

NQQ 2025-12-15

HyperVue™ Imaging System - Integrated

Applicant Spectrawave, Inc.

K number K253101

View details →

NQQ 2025-10-07

deepLive (OSP12 + DMS)

Applicant Damae Medical

K number K252851

View details →

NQQ 2025-07-16

HyperVue™ Software

Applicant Spectrawave, Inc.

K number K251198

View details →

NQQ 2025-07-02

OPUSWAVE Dual Sensor Imaging System

Applicant Terumo Cardiovascular Systems Thi Plant

K number K250684

View details →

NQQ 2025-06-23

OPXION Optical Skin Viewer (OPXSV1-01F)

Applicant Opxion Technology, Inc.

K number K242924

View details →

NQQ 2025-04-11

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

Applicant Shenzhen Vivolight Medical Device & Technology Co., Ltd.

K number K242098

View details →

NQQ 2025-03-20

Starlight Imaging Catheter

Applicant Spectrawave, Inc.

K number K243016

View details →

NQQ 2024-08-16

HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))

Applicant Gentuity, LLC

K number K242239

View details →

NQQ 2024-07-09

deepLive

Applicant Damae Medical

K number K240610

View details →

NQQ 2023-09-08

ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6

Applicant ABBOTT MEDICAL

K number K232386

View details →

NQQ 2023-06-07

HyperVue™ Imaging System

Applicant Spectrawave, Inc.

K number K230691

View details →

NQQ 2023-02-28

SpectraWAVE Imaging System

Applicant Spectrawave, Inc.

K number K221257

View details →

NQQ 2021-06-08

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

Applicant ABBOTT MEDICAL

K number K210458

View details →

NQQ 2021-02-25

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System

Applicant Perimeter Medical Imaging Ai, Inc.

K number K203578

View details →

NQQ 2020-09-02

ApolloVue S100 Image System

Applicant Apollo Medical Optics, Ltd.

K number K201552

View details →

NQQ 2020-02-20

Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter

Applicant Gentuity, LLC

K number K192922

View details →

NQQ 2019-07-19

NvisionVLE Low-profile Optical Probe

Applicant Ninepoint Medical, Inc.

K number K191117

View details →

NQQ 2019-04-02

Ilumien Optis, Optis Integrated, Optis Mobile

Applicant St. Jude Medical (Now Abbott Medical)

K number K183320

View details →

NQQ 2019-03-26

OTIS Optical Coherence Tomography SYstem

Applicant Perimeter Medical Imaging, Inc.

K number K190404

View details →

NQQ 2018-11-02

NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System

Applicant Ninepoint Medical, Inc.

K number K182616

View details →

NQQ 2018-10-16

NvisionVLE Imaging System, NvisionVLE Optical Probe

Applicant Ninepoint Medical, Inc.

K number K182261

View details →

NQQ 2017-08-25

OTIS Optical Coherence Tomography System

Applicant Perimeter Medical Imaging, Inc.

K number K171560

View details →

NQQ 2016-11-29

LuminScan (TM) Imaging System

Applicant Micro-Tech (Nanjing) Co., Ltd.

K number K162466

View details →

NQQ 2016-08-11

VivoSight Dx Topical OCT System

Applicant Michelson Diagnostics, Ltd.

K number K153283

View details →

NQQ 2016-06-29

OPTIS Metallic Stent Optimization E.4 SW

Applicant Lightlab Imaging, Inc.

K number K160878

View details →

NQQ 2016-05-13

Perimeter Otis™ 1.0 Optical Coherence Tomography System

Applicant Perimeter Medical Imaging, Inc.

K number K160240

View details →

NQQ 2016-02-16

NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System

Applicant Ninepoint Medical, Inc.

K number K153479

View details →

NQQ 2013-04-25

NVISION VLE IMAGING SYSTEM

Applicant Ninepoint Medical, Inc.

K number K120800

View details →

NQQ 2013-01-30

ILUMIEN OPTIS

Applicant Lightlab Imaging, Inc.

K number K123369

View details →

NQQ 2012-07-25

NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER

Applicant Ninepoint Medical, Inc.

K number K121195

View details →

NQQ 2011-12-16

NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER

Applicant Ninepoint Medical, Inc.

K number K112770

View details →

NQQ 2011-08-10

C7 XR IMAGING SYSTEM

Applicant Lightlab Imaging, Inc.

K number K111201

View details →

NQQ 2010-12-01

TOMOPHASE OCTIS

Applicant Tomophase Corporation

K number K102599

View details →

NQQ 2010-04-30

C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES

Applicant Lightlab Imaging, Inc.

K number K093857

View details →

NQQ 2010-01-05

VIVOSIGHT TOPICAL OCT SYSTEM

Applicant Michelson Diagnostics, Ltd.

K number K093520

View details →

NQQ 2004-11-19

IMALUX NIRIS IMAGING SYSTEM

Applicant Imalux Corporation

K number K042894

View details →

NQQ 2004-03-01

IMALUX OCT IMAGING SYSTEM

Applicant Imalux Coporation

K number K033783

View details →