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510(k) Data Aggregation
K Number
K243535Device Name
Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
Manufacturer
Shanghai SeeGen Photoelectric Technology Co., Ltd.
Date Cleared
2025-03-07
(112 days)
Product Code
FBN
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Shanghai SeeGen Photoelectric Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexible Video-Choledochoscope is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.
Device Description
Flexible Video-Choledochoscope is a kind of medical instrument, also known as optical camera, which can enter into the human biliary and pancreatic duct for observation and diagnosis. The operator delivers the optical camera system to the site of diagnosis and treatment by means of a mechanical part with a flexible insertion tube and a system of bends. This device must be used with a duodenoscope. The product is equipped with tiny size digital imaging parts -- photoelective sensors "CMOS", on which the objects in human cavity will be transferred though lens optical system, and converts light signals. The electrical signal will be transferred to Imaging Processor System (Including Light Source) and display images on its monitor output for doctor observation and diagnosis.
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K Number
K241532Device Name
Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)
Manufacturer
Shanghai SeeGen Photoelectric Technology Co., Ltd.
Date Cleared
2024-10-22
(145 days)
Product Code
FET, KQM
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Shanghai SeeGen Photoelectric Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexible Video-Choledo-Cysto-Ureteroscope System is indicated for endoscopic examination in the urinary tract and can be used percutaneously to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. The Flexible Video-Choledo-Cysto-Ureteroscope System is also indicated for the examination of bile ducts surgically, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.
Device Description
Imaging Processor System (Including Light Source) is composed of lighting system, image processing board. The lighting system provides the light source for the endoscope probe at the back end. The image processing board receives electronic signals from the front-end camera module and processes them, and finally transmits them to the display through the video interface. Flexible Video-Choledo-Cysto-Ureteroscope is a kind of medical electronic optical instrument, also known as optical camera, which can enter into the human bladder, ureter, biliary and pancreatic duct for observation and diagnosis. The operator delivers the optical camera system to the site of diagnosis and treatment by means of a mechanical part with a flexible insertion tube and a system of bends. The product is equipped with tiny size digital imaging parts -- photoelectric sensors "CMOS", on which the objects in human cavity will be transferred though lens optical system, and converts light signals into electrical signals. The electrical signal will be transferred to Imaging Processor System (Including Light Source) and display images on it's monitor output for doctor observation and diagnosis.
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K Number
K222499Device Name
Disposable Endoscope Valves Kit
Manufacturer
Shanghai SeeGen Photoelectric Technology Co., Ltd.
Date Cleared
2023-11-22
(461 days)
Product Code
ODC
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Shanghai SeeGen Photoelectric Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The values are used in conventional gastrointestinal endoscope to control the functions of water/gas injection and suction during the endoscopic operation.
Device Description
Disposable Endoscope Valves Kit consists of Water/gas button, Attraction button, Biopsy cap and Water injection adapter. Disposable Endoscope Valves Kit connect the endoscope operating handle matched with the model, and install the water gas button into the water gas port of the operating handle; Align the positioning boss of the suction button with the card slot of the operating handle and install it into the suction port; Install the biopsy cap into the clamp opening of the operating handle.
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