System, Imaging, Optical Coherence Tomography (oct)

Product Code: NQQ

Radiology Diagnostic Ultrasound Devices

Definition: This Device Uses Back-reflected Light To Create Two-dimensional Images Versus Back-reflected Sound Waves As Are Used In Ultrasound Imaging.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 892.1560

• Radiation Type: Acoustic
• Radition Safety: Abbreviated
• Annual Reports: No

Products Classified as NQQ

5483

System, Imaging, Optical Coherence Tomography (oct)

Ultrasonic Pulsed Echo Imaging System.

Total Product Life Cycle (TPLC) Devices

5483

System, Imaging, Optical Coherence Tomography (oct)

Ultrasonic Pulsed Echo Imaging System.

FDA Consensus Standards

• System, Imaging, Optical Coherence Tomography (Oct) [37172]: 21 CFR §892.1560 🔎

Pre-market Notifications for NQQ

K210458	OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System	Abbott Medical
K203578	OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System	Perimeter Medical Imaging AI, Inc.
K201552	ApolloVue S100 Image System	Apollo Medical Optics, Ltd.
K192922	Gentuity HF-OCT Imaging System With Vis-Rx Micro-Imaging Catheter	Gentuity, LLC
K191117	NvisionVLE Low-profile Optical Probe	NinePoint Medical, Inc
K190404	OTIS Optical Coherence Tomography SYstem	Perimeter Medical Imaging, Inc.
K183320	Ilumien Optis, Optis Integrated, Optis Mobile	St. Jude Medical (now Abbott Medical)
K182616	NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System	NinePoint Medical, Inc.
K182261	NvisionVLE Imaging System, NvisionVLE Optical Probe	NinePoint Medical, Inc.
K171560	OTIS Optical Coherence Tomography System	Perimeter Medical Imaging, Inc.
K162466	LuminScan (TM) Imaging System	MICRO-TECH (NANJING) CO.,LTD.
K160878	OPTIS Metallic Stent Optimization E.4 SW	LIGHTLAB IMAGING, INC.
K160240	Perimeter Otis™ 1.0 Optical Coherence Tomography System	PERIMETER MEDICAL IMAGING, INC.
K153479	NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm Balloon, NvisionVLE Marking Probe, 17mm Balloon,NvisionVLE Marking Probe, 14mm Balloon, NvisionVLE Inflation System	NINEPOINT MEDICAL, INC
K153283	VivoSight Dx Topical OCT System	Michelson Diagnostics Ltd

Global Unique Device Identification Database

• 00812059021994: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• 00812059021987: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• 00812059021925: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• 00812059021918: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• 00812059021536: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• 00812059021482: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• 00812059021444: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• 00812059021437: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• 00812059021420: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• 00812059021390: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• 00812059021383: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• 00812059021338: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• 00812059020560: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• 00812059020126: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• 00812059020003: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Maude Adverse Events

PIU2 C7XR	ST. JUDE MEDICAL CATD	2020-01-09
C8I ? OCT INTEGRATED SYSTEM	ST. JUDE MEDICAL	2019-11-15
ILUMIEN IMAGING SYSTEM	ST. JUDE MEDICAL CATD	2019-07-17
FRU M5 ENGINE R RFB	ST. JUDE MEDICAL CATD	2019-06-28
C8I ? OCT INTEGRATED SYSTEM	ST. JUDE MEDICAL CATD	2019-04-24
NVISIONVLE OPTICAL PROBE	NINEPOINT MEDICAL, INC.	2019-04-24
NVISIONVLE OPTICAL PROBE	NINEPOINT MEDICAL, INC.	2019-04-12
NVISIONVLE LOW-PROFILE OPTICAL PROBE	NINEPOINT MEDICAL, INC.	2018-04-13
NVISIONVLE LOW-PROFILE OPTICAL PROBE	NINEPOINT MEDICAL, INC.	2018-04-13
NVISIONVLE OPTICAL PROBE	NINEPOINT MEDICAL, INC.	2018-03-20
NVISIONVLE OPTICAL PROBE	NINEPOINT MEDICAL, INC.	2018-03-09
ILUMIEN OPTIS SYSTEM	ST. JUDE MEDICAL	2017-10-30
DRAGONFLY? OPTIS? CATHETER	ST. JUDE MEDICAL CATD	2017-02-23
NVISIONVLE MARKING PROBE	NINEPOINT MEDICAL, INC.	2017-02-14
NVISIONVLE OPTICAL PROBE	NINEPOINT MEDICAL, INC.	2016-07-06
NVISIONVLE OPTICAL PROBE	NINEPOINT MEDICAL, INC.	2016-03-23
NVISIONVLE OPTICAL PROBE	NINEPOINT MEDICAL, INC.	2015-09-16
NVISION VLE OPTICAL PROBE	NINEPOINT MEDICAL INC.	2015-04-21
NVISIONVLE OPTICAL PROBE, 20MM BALLOON	NINEPOINT MEDICAL INC.	2015-02-06
NVISIONVLE OPTICAL PROBE	NINEPOINT MEDICAL INC.	2014-11-21
DRANGONFLY	LIGHTLAB IMAGING, INC.	2013-10-17
DRAGONFLY	ST. JUDE MEDICAL	2013-04-03
DRAGONFLY IMAGING CATHETER	ST. JUDE MEDICAL	2013-03-19
DRAGONFLY IMAGING CATHETER	ST. JUDE MEDICAL	2012-10-11
DRAGONFLY	LIGHT LAB IMAGING, DIV ST. JUDE MEDICAL	2012-05-16
DRAGONFLY IMAGING CATHETER	ST JUDE MEDICAL	2012-04-11
DRAGONFLY IMAGING CATHETER	ST JUDE MEDICAL	2012-03-27
C7 DRAGONFLY IMAGING CATHETER	ST JUDE MEDICAL	2012-03-16
C7 DRAGONFLY	ST. JUDE MEDICAL, INC.	2011-12-05
C7 DRAGONFLY IMAGING CATHETER	ST. JUDE MEDICAL	2011-04-22