Scivita 4KINSIGHT ICG imaging system

GUDID 16971381251415

The Scivita 4KINSIGHT ICG Imaging System consists of a 4KINSIGHT UHD Fluorescence Imaging System, a Near Infrared LED Light Source, and a 4K UHD LAPAROSCOPE.Upon intravenous administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraop erative cholangiography. The Scivita 4KINSIGHT ICG Imaging System is indicated for use to provide real time endoscopic visible and near infrared fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive s urgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for bil iary duct visualization. Upon interstitial administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessel s and lymph nodes.

SCIVITA MEDICAL TECHNOLOGY CO., LTD.

Rigid optical laparoscope

Primary Device ID	16971381251415
NIH Device Record Key	98d25dfb-6ad6-44bf-937c-e91d4508678d
Commercial Distribution Status	In Commercial Distribution
Brand Name	Scivita 4KINSIGHT ICG imaging system
Version Model Number	4K1045L
Company DUNS	544519831
Company Name	SCIVITA MEDICAL TECHNOLOGY CO., LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 700 KiloPascal and 1060 KiloPascal
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971381251418 [Primary]
GS1	16971381251415 [Package] Contains: 06971381251418 Package: [2 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K221252

FDA Product Code

GCJ	Laparoscope, General & Plastic Surgery