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510(k) Data Aggregation

    K Number
    K090800
    Device Name
    VS-100 ILLUMINATION AND IMAGING SYSTEM
    Manufacturer
    SCHOELLY IMAGING, INC.
    Date Cleared
    2009-05-18

    (55 days)

    Product Code
    FET
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHOELLY IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K090601
    Device Name
    FSC 2
    Manufacturer
    SCHOELLY IMAGING, INC.
    Date Cleared
    2009-05-11

    (67 days)

    Product Code
    NTN, LED, XXX
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHOELLY IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FSC 2 is intended to be used in conjunction with endoscopic devices to provide illumination and video visualization of optical images to visualize and observe body spaces.
    Device Description
    The Schoelly FSC 2 is a camera hand piece with built-in LED illumination intended to be used with Schoelly endoscopes. The light source provides illumination to the area under endoscopic examination. The compact camera component attaches to the proximal eyepiece of the endoscope via the Flexilock connector. Optically captured images are transferred to the camera. converted to an electrical signal, and amplified for output to accessories such as a computer.
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    K Number
    K083553
    Device Name
    NASO-LARYNGO-PHARYNGOSCOPE
    Manufacturer
    SCHOELLY IMAGING, INC.
    Date Cleared
    2009-01-16

    (46 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHOELLY IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Schoelly Naso-Laryngo-Pharyngoscope is intended to be used by qualified surgeons and physicians to visualize and observe the pharynx and the larynx.
    Device Description
    The Schoelly Naso-Laryngo-Pharyngoscope is a flexible and steerable fiberoptic endoscope for diagnostic purposes. Manufactured in two resolutions, 12,000 and 16,000 pixels.
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    K Number
    K060899
    Device Name
    FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE
    Manufacturer
    SCHOELLY IMAGING, INC.
    Date Cleared
    2007-03-02

    (333 days)

    Product Code
    FAJ, HIH, REG
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHOELLY IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexilux II Cystoscope is - like the predicate device - used to permit direct viewing of the male urethra, prostate, and bladder for purpose of performing diagnostic and surgical procedures. The Flexilux II Hysteroscope is - like the predicate device - used to illuminate and visualize the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. The Cystoscope is used to visualize the body cavities, hollow organs and canals during diagnostic and, in conjunction with additional instruments, therapeutic procedures. The Hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
    Device Description
    The Flexilux II Hysteroscope and Cystoscope (herein after; Flexilux II Endoscope) are rigid type endoscopes with traditional compact objectives and rod-lens system. The basic design of the Flexilux II Endoscope is similar to those legally available for sale in the U.S.A... It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical stainless steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
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    K Number
    K053412
    Device Name
    FLEXISCOPE, MODELS 50MH AND 50 MHC
    Manufacturer
    SCHOELLY IMAGING, INC.
    Date Cleared
    2006-02-23

    (78 days)

    Product Code
    FWF, GCT
    Regulation Number
    878.4160
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHOELLY IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FlexiScope 50MH / 50MHC is indicated for use in conjunction with endoscopic devices to provide illumination and video visualization of optical images.
    Device Description
    The Schoelly FlexiScope 50MH / 50MHC system is comprised of a camera handpiece and a combination light source / video processor; the system is intended for use with currently marketed endoscopes. The light source utilizes visible light to provide illumination of the area under endoscopic examination. The compact camera system component attaches to the proximal eyepiece of the user-supplied flexible or rigid endoscope. Images are optically captured via the endoscope. The image is transferred to the camera's CCD (charge coupled device) sensor through the scope objective lens, where it is converted to an electrical signal and amplified for output to accessories such as a monitor, printer, etc.
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