Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K243535
    Device 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
    876.1500
    Why 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.
    Ask a Question
    K Number
    K241532
    Device 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
    876.1500
    Why 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.
    Ask a Question
    K Number
    K222499
    Device Name
    Disposable Endoscope Valves Kit
    Manufacturer
    Shanghai SeeGen Photoelectric Technology Co., Ltd.
    Date Cleared
    2023-11-22

    (461 days)

    Product Code
    ODC
    Regulation Number
    876.1500
    Why 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.
    Ask a Question
    K Number
    K222261
    Device Name
    Flexible Video-Choledochoscope System
    Manufacturer
    Shanghai SeeGen Photoelectric Technology Co., Ltd
    Date Cleared
    2023-04-20

    (266 days)

    Product Code
    FBN, FET, KQM, NTN
    Regulation Number
    876.1500
    Why 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 System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Flexible Video-Choledochoscope System comprises two components: the Flexible Video- Choledochoscope and Imaging Processor System (Including Light Source). The Flexible Video-Choledochoscope is indicated for use in diagnostic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The imaging processor system (including the light source) provides illumination for Flexible Video-Choledochoscope and is also used to receive the signal from the endoscope, then convert it into an image and display it on the examination monitor.
    Device Description
    Flexible Video-Choledochoscope System is composed of sterile Flexible Video-Choledochoscope and a non-sterile Imaging Processor System (Including Light Source). The Flexible Video-Choledochoscope is composed of Operation section, Light-guide Section, Insertion a Distal tip and bending section. The Operation Section is pulled by the wire rope to control the bending direction of the Distal tip. The Light-guide section transmits the illumination light from the image processor to the Distal tip. The Insertion Tube is used to guide it into other instruments or cavity of the body. The Distal tip contains a camera system and a lighting system for illumination and observation. 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-Choledochoscope is a kind of medical electronic optical 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. 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 its monitor output for doctor observation and diagnosis.
    Ask a Question
    K Number
    K211686
    Device Name
    Flexible Video-Choledo-Cysto-Ureteroscope System
    Manufacturer
    Shanghai SeeGen Photoelectric Technology Co., Ltd
    Date Cleared
    2022-02-22

    (265 days)

    Product Code
    FGB, FBN, KQM
    Regulation Number
    876.1500
    Why 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
    Flexible Video-Choledo-Cysto-Ureteroscope System is composed of sterile Flexible Video-Choledo-Cysto-Ureteroscope and an non-sterile Imaging Processor System (Including Light Source).The Flexible Video-Choledo-Cysto-Ureteroscope is composed of Control Section, Light-guiding Section, Connector Section, Insertion Tube and Distal End. The Control Section is pulled by the wire rope to control the bending direction of the Distal End. The Light-guide section transmits the illumination light from the image processor to the Distal End. The Insertion Tube is used to guide it into other instruments or cavity of the body. The Distal End contains a camera system and a lighting system for illumination and observation. 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.
    Ask a Question

    Page 1 of 1