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510(k) Data Aggregation

    K Number
    K141366
    Device Name
    VIDEO BRONCHOSCOPE SYSTEM
    Manufacturer
    SCHOLLY FIBEROPTIC GMBH
    Date Cleared
    2014-12-17

    (208 days)

    Product Code
    EOQ, EOO
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHOLLY FIBEROPTIC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Schoelly Video Bronchoscope System is intended for use by physicians for diagnostic and therapeutic procedures in nasopharyngeal endoscopy, bronchoscopy, tracheoscopy, and laryngoscopy. The Schoelly Video Bronchoscope is intended to provide visualization via a video monitor.
    Device Description
    The Schoelly Video Bronchoscope System consists of a flexible and steerable endoscope with an integral working/suction channel and a camera control unit (CCU) for regulation of light intensity and connection to a commercially available monitor, PC, and medical video and image capture unit for image display or image documentation. The endoscope has outer surfaces mainly made from plastic. The endoscope handle incorporates a control lever to bend the distal tip and a working channel port enabling the insertion of instruments for access to the endoscope tip through the working channel. For sampling of tracheobronchial secretion or irrigation, the endoscope further incorporates a suction channel with the suction valve port located at the endoscope handle and is accompanied by a suction valve/seal accessory . Suction and working channel converge within the endoscope handle, thus within the endoscope shaft there is only one lumen towards the endoscope tip. The suction power can be adjusted at the suction valve which is rotatable by 360°. The endoscope further comprises a ventilation system to protect the endoscope shaft during sterilization. The exhaust valve at the endoscope handle can also be used for leakage testing. For this purpose the system is accompanied by a leakage tester and accessories. LED light sources are integrated in the endoscope handle to illuminate the anatomy under investigation. Light is transmitted through fiberoptic bundles to provide standard dual wide angle illumination as well as a narrower light beam which acts as a focused spot light thereby allowing for an improved visualization of more distal anatomical structures (DeepVu illumination). The DeepVu function can be activated by pressing a button at the endoscope handle. The video signal is captured by a CMOS imaging sensor located at the tip of the endoscope and transferred to the CCU. Images can be frozen and stored on a PC or medical video and image capture unit by pressing a button at the endoscope handle. The Schoelly Video Bronchoscope System is delivered in a non-sterile condition and is already CE marked.
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    K Number
    K133682
    Device Name
    SCHOELLY ARTHROSCOPE
    Manufacturer
    SCHOLLY FIBEROPTIC GMBH
    Date Cleared
    2014-06-02

    (182 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHOLLY FIBEROPTIC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K984556
    Device Name
    SCICAN CLASSIC
    Manufacturer
    SCHOLLY FIBEROPTIC GMBH
    Date Cleared
    1999-02-09

    (48 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHOLLY FIBEROPTIC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SciCan Classic and accessories is to provide video images of the mouth and oral structures, dental cavities, dental pulps, dental canal morphology. It is used to perform various diagnostic procedures, to provide educational information to patients as well as to other clinical personnel and to provide documentation for patient records and for insurance companies. SciCan Classic also is used for inspection of reliable diagonsis of border gaps when dealing with inlays. Additionally it acts as an effective caries detector during the examination of areas of the mouth which are normally difficult to approach. Further indications for use are extra-oral imaging of the whole face and of the mouth, outline imaging of the quadrants and macroscopic images of the dental enamel. The SciCan Classic and accessories are indicated for use when video images are desired to provide visual information during dental examinations and procedures.
    Device Description
    The SciCan Classic is a video camera system with a modular design due to a handpiece system with interchangeable optics. It uses a CCD ½" camera chip and provides fiber optic illumination by an integrated light source with automatic exposure control. It has removable and interchangeable probe options (90° probes, 0° probe). It supports NTSC / PAL video systems and has a power consumption of 150 Watt.
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