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510(k) Data Aggregation

    K Number
    K201325
    Device Name
    Optomed Smartscope M5 with Optomed Smartscope FA
    Manufacturer
    Optomed Oyj
    Date Cleared
    2020-11-20

    (186 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Optomed Oyj

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Optomed Smartscope M5 digital camera with Smartscope FA optics module is intended to capture fluorescein angiograms of the human eye.
    Device Description
    Optomed Smartscope M5 camera with Smartscope FA optics module is designed for use in a medical environment. Captured images and video are used for documentation and consultation. Optomed Smartscope M5 camera has a memory card where captured images and recorded videos are saved. Optomed Smartscope M5 camera is used with interchangeable optics modules previously cleared Smartscope EY4 and Smartscope ES2 and subject device Smartscope FA. Optics modules are attached to the camera with bayonet connectors. Optomed Smartscope FA optics module is designed for fundus fluorescein angiography imaging of the human eye. Optomed Smartscope FA optics module includes two light sources: Blue light and infrared light, optical component that reflects light to the optical path and lenses that guide light through the pupil to the back of the eye and back to the camera sensor. Optomed Smartscope FA optics module has nine internal fixation targets for the patient to fixate on during imaging. Optomed Smartscope FA optics module receives power from Optomed Smartscope M5 digital camera. Optomed Smartscope M5 camera has a WLAN module inside and when WLAN is used, Optomed Smartscope M5 camera transfers captured images and recorded videos to the PC automatically immediately after imaging. Images and videos can also be transferred to PC from the memory card when the camera is placed on Charging Station and the USB cable is connected between Charging Station and the PC. The image data transfer method to PC is similar as with any other USB mass storage device. Optomed Smartscope M5 camera has a rechargeable Ni-MH battery that is charged when the camera is placed on Charging Station, which is connected to the mains by power supply cable. Charging Station can also be used as an external battery charger for the spare battery included in sales case. When Optomed Smartscope M5 camera is not used, it may be stored on Charging Station. Storing the device on Optomed Smartscope M5 camera Charging Station is not harmful for the battery.
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