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510(k) Data Aggregation

    K Number
    K242010
    Device Name
    Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1)
    Manufacturer
    Shenzhen Sanping Image Technology Co., Ltd.
    Date Cleared
    2025-03-14

    (247 days)

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

    Shenzhen Sanping Image Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Single-use Bronchoscopes have been designed to be used with the Electronic Endoscope Imaging Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The Bronchoscope System is for use in a hospital environment. The Single-use Bronchoscope is a single-use device designed for use in adults.
    Device Description
    The Single-use Bronchoscope is a sterile single used flexible bronchoscope. The Electronic Endoscope Imaging Processor is a reusable monitor. The light emitted by the LED cold light source at the distal tip of the Single-use Bronchoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output of the Electronic Endoscope Imaging Processor via the encoding circuit. The Electronic Endoscope Imaging Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the monitor. The Electronic Endoscope Imaging Processor also controls the brightness of the LEDs on the endoscope. The optical components and their arrangement at the distal tip for all models of the Single-use Bronchoscope are identical. The Single-use Bronchoscope is single-use medical devices that are sterilized with ethylene oxide and intended for use in adults. This product is accompanied by an electronic endoscopic image processor, which supports the use of medical monitors. The electronic bronchoscope system is used for endoscopic diagnosis or treatment, and the processor collects, processes, stores, and transmits images of the human body cavity to the monitor.
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