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510(k) Data Aggregation
K Number
K171238Device Name
KARL STORZ ICG Imaging System
Manufacturer
Karl Storz Endoscopy- America, Inc.
Date Cleared
2017-05-25
(28 days)
Product Code
OWN
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Karl Storz Endoscopy- America, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.
The KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic 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 duct, common bile duct and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the KARL STORZ Endoscopic ICG 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.
The KARL STORZ VITOM II ICG System is intended for capturing fluorescent mages for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light.
Device Description
The KARL STORZ ICG Imaging System is used to provide real-time high definition (HD) endoscopic or telescope images of visible (VIS) and near-infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive surgery as well as plastic, micro- and reconstructive surgical procedures.
The overall system includes a 5mm &10mm HOPKINS ICG/NIR Endoscope for use in minimally invasive procedures and a VITOM II ICG/NIR Telescope for use in plastic, micro- and reconstructive surgical procedures for VIS and NIR illumination and imaging, a light source with foot switch for emission of VIS and NIR illumination, a color video camera head capable of capturing both VIS and NIR imaging, and KARL STORZ ICG Kit. Additional accessories used with the KARL STORZ ICG Imaging System include two standard fiber-optic light cables for transmission of VIS and NIR light and the Image1S Camera Control Unit (CCU).
The KARL STORZ ICG Imaging System can be used with any medical grade HD monitor with a DVI-D or 3G-SDI input.
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