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510(k) Data Aggregation

    K Number
    K981958
    Device Name
    LEISEGANG VIDEO COLPOSCOPE
    Manufacturer
    NETOPTIX CORP.
    Date Cleared
    1998-10-19

    (137 days)

    Product Code
    HEX
    Regulation Number
    884.1630
    Why did this record match?
    Applicant Name (Manufacturer) :

    NETOPTIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Leisegang Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The image can be viewed only on a color monitor.
    Device Description
    The Galileo Leisegang Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The image can be viewed only on a color monitor. The Leisegang Video Colposcope consists of a CCD camera with a halogen light source, green filter and is mounted on a mobile base.
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    K Number
    K981828
    Device Name
    GALILEO DISPOSABLE HYSTEROSCOPES
    Manufacturer
    NETOPTIX CORP.
    Date Cleared
    1998-07-07

    (46 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    NETOPTIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Galileo Disposable Hysteroscopes are endoscopes intended for visualization of the cervical canal and uterine cavity for diagnostic and surgical procedures during gynecological procedures. The Hysteroscope diagnostic indications include abnormal uterine bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea and pelvic pain. The Hysteroscope is indicated for surgical procedures such as directed biopsy, removal of submucous fibroids and large polyps, submucous myomectomy, transection of intrauterine adhesions and septa and endometrial ablation.
    Device Description
    The Galileo Disposable Hysteroscopes are a line of disposable endoscopes based on existing endoscope technology. The Galileo Disposable Hysteroscopes will be available in several sizes and lengths. The Galileo Disposable Hysteroscopes are fiber optic design endoscopes that are offered in disposable configurations only. Fiberoptic design endoscopes function by light being transmitted from a standard external high intensity light source through optical fibers to the distal tip of the endoscope. The image of the target is then transmitted from the distal end via an objective lens and a fiberoptic imaging bundle to a proximal eyepiece. The image can be viewed directly or it may be transmitted through a video camera to a video monitor. The Disposable Hysteroscopes are offered with a coupler that includes a light source which is provided by Galileo Electro-Optics Corporation. The Galileo coupler is compatible only with the Galileo Disposable Hysteroscopes and the other cleared commercially available Galileo endoscopes.
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    K Number
    K974297
    Device Name
    GALILEO DISPOSABLE HYSTEROSCOPES
    Manufacturer
    NETOPTIX CORP.
    Date Cleared
    1998-02-13

    (88 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    NETOPTIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Galileo Hysteroscopes are endoscopes intended for direct visualization of the cervical canal and uterine cavity for diagnostic procedures during gynecological procedures. The Hysteroscope diagnostic include abnormal uterine bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea and pelvic pain.
    Device Description
    The Galileo Disposable Hysteroscopes are a line of disposable endoscopes based on existing endoscope technology. The Galileo Disposable Hysteroscopes will be available in 2.8 mm OD X 270 mm length size. The Galileo Disposable Hysteroscopes are fiber optic design endoscopes that are offered in disposable configurations only. Fiberoptic design endoscopes function by light being transmitted from a standard external high intensity light source through optical fibers to the distal tip of the endoscope. The image of the target is then transmitted from the distal end via an objective lens and a fiberoptic imaging bundle to a proximal eyepiece. The image can be viewed directly or it may be transmitted through a video camera to a video monitor. The Disposable Hysteroscopes are offered with a coupler that includes a light source which is provided by Galileo Electro-Optics Corporation. The Galileo coupler is compatible only with the Galileo Disposable Hysteroscopes and the other cleared commercially available Galileo endoscopes.
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    K Number
    K971896
    Device Name
    GALILEO HIGH RESOLUTION MICRO COUPLER
    Manufacturer
    NETOPTIX CORP.
    Date Cleared
    1997-10-10

    (141 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    NETOPTIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Galileo Micro Coupler is indicated for use with endoscopy. It is an interface which allows the transmission of optical image from the endoscope to a video camera for video recording or viewing on a monitor.
    Device Description
    The Galileo Micro Couplers are a line of reusable optical couplers used in the transfer of image from an endoscope to a video camera for either image recording or viewing on a monitor. The Galileo Micro Couplers are available in several configurations which will allow coupling to different Endoscopes and camera.
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