Home GUDID 00812059020126 OPTIS™
Primary DI 00812059020126
Brand OPTIS™
Company LIGHTLAB IMAGING, INC.
Model C408653
Catalog number C408653
Device description Mobile Workstation
Published 2015-09-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name NQQ SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00812059020126 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00812059020126 00812059020126 812059020126 0812059020126
GMDN Terms# Term, Definition table Term Definition Coronary optical coherence tomography system An assembly of optical and computer-based devices that use a broad-bandwidth light beam for optical coherence tomography (OCT) to provide high-resolution images (e.g., 5 to 40 microns) of the coronary intravasculature. It typically consists of a main operator's console which includes a computer for image storage, keyboard/mouse controls, and a visual display unit (VDU); audio recording facilities; and a printer. The system includes an optical-imaging catheter which is connected to the console for transmission of the images from the intravascular site. The system may be used during interventional cardiology, radiology, or diagnostic angiography.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 0.05 KiloPascal 0.106 KiloPascal Handling Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Temperature -25 Degrees Celsius 50 Degrees Celsius Special Storage Condition, Specify 0 0 Keep Dry. Do not use the OPTIS Mobile System if it has been dropped or in another way exposed to mechanical or electrical damage or if liquids have penetrated the housing. Storage Environment Atmospheric Pressure 0.05 KiloPascal 0.106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -25 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 018493531 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00199874783659 LIA Console LEADOPTIK INC. NQQ 2026-06-01 05415067054920 Ultreon™ LIGHTLAB IMAGING, INC. NQQ 2026-05-19 00812763011007 OPUSWAVE Terumo Cardiovascular Systems Corporation NQQ 2026-05-13 06975417183858 Pantheris Zylox-Tonbridge Medical Technology Co., Ltd. NQQ 2026-03-21 06975417183865 Pantheris Zylox-Tonbridge Medical Technology Co., Ltd. NQQ 2026-03-21 06975417183872 Pantheris Zylox-Tonbridge Medical Technology Co., Ltd. NQQ 2026-03-21 06975417183889 Pantheris Zylox-Tonbridge Medical Technology Co., Ltd. NQQ 2026-03-21 06971141530494 Cornaris Intravascular Imaging System Shenzhen Vivolight Medical Device & Technology Co., Ltd. NQQ 2025-09-28 06971141530500 Cornaris Intravascular Imaging System Shenzhen Vivolight Medical Device & Technology Co., Ltd. NQQ 2025-09-28 03775000102715 deepLive DAMAE MEDICAL NQQ 2025-09-24 05415067053879 ILUMIEN™ OPTIS™ to OPTIS™ LIGHTLAB IMAGING, INC. NQQ 2025-07-31 05415067047694 Ultreon™ LIGHTLAB IMAGING, INC. NQQ 2024-03-29 00860008045508 Starlight Imaging Catheter Spectrawave, Inc. NQQ 2024-02-23 00860008045515 HyperVue Imaging System Spectrawave, Inc. NQQ 2024-02-23 00851354004509 Lightbox L3 AVINGER, INC. NQQ 2024-01-29 05415067048882 AptiVue™ LIGHTLAB IMAGING, INC. NQQ 2023-09-29 06932503570022 Luminscan(TM) Disposable Imaging Kit Micro-Tech (Nanjing) Co., Ltd. NQQ 2023-08-11 06932503570039 Luminscan(TM) Disposable Imaging Kit Micro-Tech (Nanjing) Co., Ltd. NQQ 2023-08-11 06932503570046 Luminscan(TM) Disposable Imaging Kit Micro-Tech (Nanjing) Co., Ltd. NQQ 2023-08-11 06932503570053 Luminscan(TM) Disposable Imaging Kit Micro-Tech (Nanjing) Co., Ltd. NQQ 2023-08-11 06932503570060 Luminscan(TM) Disposable Imaging Kit Micro-Tech (Nanjing) Co., Ltd. NQQ 2023-08-11 06932503570077 Luminscan(TM) Disposable Imaging Kit Micro-Tech (Nanjing) Co., Ltd. NQQ 2023-08-11 06932503570084 Luminscan(TM) Disposable Imaging Kit Micro-Tech (Nanjing) Co., Ltd. NQQ 2023-08-11 06932503570091 Luminscan(TM) Disposable Imaging Kit Micro-Tech (Nanjing) Co., Ltd. NQQ 2023-08-11 06932503570107 Luminscan(TM) Disposable Imaging Kit Micro-Tech (Nanjing) Co., Ltd. NQQ 2023-08-11 16932503570029 MT Micro-Tech (Nanjing) Co., Ltd. NQQ 2023-08-11 16932503570036 MT Micro-Tech (Nanjing) Co., Ltd. NQQ 2023-08-11 16932503570043 MT Micro-Tech (Nanjing) Co., Ltd. NQQ 2023-08-11 16932503570050 MT Micro-Tech (Nanjing) Co., Ltd. NQQ 2023-08-11 16932503570067 MT Micro-Tech (Nanjing) Co., Ltd. NQQ 2023-08-11
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