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4KINSIGHT UHD Fluorescence Imaging System

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 4KIR01Model 4KIR01 4KIR02 4KIR03 4KIR04 4KIR05 4KIR06 4KIR07 4KIR08 4KIR09 4KIR10 4KIR11 4KIR12

by Scivita Medical Technology Co., Ltd.

Identity

Trade Name
4KINSIGHT UHD Fluorescence Imaging System EUDAMEDFDA UDI
Generic Name
Endoscopic video image processing unit FDA UDI
Device Name
4KINSIGHT UHD Fluorescence Imaging System EUDAMED
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 intraoperative 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 surgery 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 biliary 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 vessels and lymph nodes. FDA UDI
Model / Reference
4KIR01 4KIR02 4KIR03 4KIR04 4KIR05 4KIR06 4KIR07 4KIR08 4KIR09 4KIR10 4KIR11 4KIR12 EUDAMED
4KIR01 EUDAMEDFDA UDI
Description
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 intraoperative 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 surgery 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 biliary 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 vessels and lymph nodes. FDA UDI

Identifiers

Primary DI / UDI-DI
06971381251456 EUDAMEDFDA UDI
Basic UDI-DI
697138125015A8G EUDAMED
Direct Marketing DI
06971381251456 EUDAMED
510(k) Number
K221252 FDA UDI
FDA Product Code
GCJ FDA UDI
IZI FDA UDI
EMDN Code
Z12020406 VIDEO PROCESSORS EUDAMED
GMDN Term
Endoscopic video image processing unit FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
892.1600 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
High-level Disinfectant FDA UDI

The 4KINSIGHT UHD Fluorescence Imaging System (4KIR01) is a cutting-edge medical device designed for detecting and diagnosing various diseases, particularly in the field of endocrinology. Equipped with advanced technology, this system provides high-quality images and accurate results, making it an essential tool for healthcare professionals. With its user-friendly interface and comprehensive features, 4KINSIGHT UHD Fluorescence Imaging System is a valuable asset in clinical settings.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scivita Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000010305
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED 274267a2-8434-43b9-9622-46f6b30a01a2 61 fields · synced Jul 17, 2026
  • FDA UDI b28d0fd4-1750-4132-9904-32da51d1f41c 35 fields · synced May 30, 2026