Scivita 4KINSIGHT ICG imaging system

GUDID 06971381250947

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.

Endoscopic light source unit, line-powered

• Primary Device ID: 06971381250947
• NIH Device Record Key: e2939119-492c-4a5f-8fd7-6a44e3e6ffe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scivita 4KINSIGHT ICG imaging system
• Version Model Number: LSIR330
• 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	06971381250947 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221252

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-29
• Device Publish Date: 2023-05-19

On-Brand Devices [Scivita 4KINSIGHT ICG imaging system]

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• 16971381251385: The Scivita 4KINSIGHT ICG Imaging System consists of a 4KINSIGHT UHD Fluorescence Imaging System
• 16971381251378: The Scivita 4KINSIGHT ICG Imaging System consists of a 4KINSIGHT UHD Fluorescence Imaging System
• 06971381250947: The Scivita 4KINSIGHT ICG Imaging System consists of a 4KINSIGHT UHD Fluorescence Imaging System