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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging 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, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, 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 visualization of biliary duct, colon, liver and uterus. 4K UHD Laparoscope is intended to be used for imaging and observation during endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.The product is composed of eyepiece, lens body, optic fiber interface and adapter.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
4K5530L
In Commercial Distribution

  • 06971381252125 ()
  • 16971381252122 ()


  • Rigid optical laparoscope
Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging 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, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, 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 visualization of biliary duct, colon, liver and uterus. 4K UHD Laparoscope is intended to be used for imaging and observation during endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.The product is composed of eyepiece, lens body, optic fiber interface and adapter.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
4K5500LR
In Commercial Distribution

  • 16971381252115 ()
  • 06971381252118 ()


  • Rigid optical laparoscope
Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging 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, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, 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 visualization of biliary duct, colon, liver and uterus. 4K UHD Laparoscope is intended to be used for imaging and observation during endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.The product is composed of eyepiece, lens body, optic fiber interface and adapter.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
4K5500L
In Commercial Distribution

  • 06971381252101 ()
  • 16971381252108 ()


  • Rigid optical laparoscope
The product is composed of the endoscopic image processor, the foot switch, the power cord and the video cables. The foot switch and the video cables are the optional accessories. This endoscopic image processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
HDVS-S100A
In Commercial Distribution

  • 06971381250473 ()


  • Endoscopic video image processing unit
Intraoral Scanner
Alliedstar Medical Equipment Co., Ltd.
NeoScan 2000
In Commercial Distribution

  • 06973993442086 ()
91001

  • Intraoral optical scanning system
NeoScan 1000 Intraoral Scanner
Alliedstar Medical Equipment Co., Ltd.
NeoScan 1000
In Commercial Distribution

  • 06973993442031 ()
91000

  • Intraoral optical scanning system
AS 200E – Intraoral Scanner
Alliedstar Medical Equipment Co., Ltd.
AS 200E
In Commercial Distribution

  • 06973993442024 ()
6583202

  • Intraoral optical scanning system
AS 100 Intraoral Scanner
Alliedstar Medical Equipment Co., Ltd.
AS 100
In Commercial Distribution

  • 06973993442017 ()
6583169

  • Intraoral optical scanning system
No Description
GE Vingmed Ultrasound AS
E95 v204 with LCD
In Commercial Distribution

  • 00840682146685 ()


  • Cardiovascular ultrasound imaging system
No Description
GE Vingmed Ultrasound AS
E80 v204 with LCD
In Commercial Distribution

  • 00840682146661 ()


  • Cardiovascular ultrasound imaging system
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