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510(k) Data Aggregation

    K Number
    K190954
    Device Name
    Fundus Camera
    Date Cleared
    2020-01-22

    (286 days)

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

    Chongqing Bio NewVision Medical Equipment Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fundus Camera RetiCam 3100 is intended to capture digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.
    Device Description
    The RetiCam 3100 fundus camera is capable to capture, display, story, manage, process digital images of the posterior and external structures of the eye continuously, in real time. The RetiCam 3100 fundus camera displays color fundus images continuously, in real time. The fundus digital image acquisition and image processing system is capable to perform measurement of the length (digital caliper), and perform area measurements, image comparison and image montage. The RetiCam 3100 fundus camera function module includes: optical module, mobile platform module, power supply module, control module, chin rest module. Optical Module The optical module is responsible for providing background light illumination, flash shooting, fixing lamp control, lens focal length adjustment and pupil monitoring of patients when the fundus camera works. The optical module mainly consists of two parts: the light source module and the lens light path module. - 1) The light source component is the source of the light source when the product works, including background light, fixation light and flash when shooting. - 2) The lens light path is responsible for reflecting the patient's fundus image to the digital camera. The functions of lens focusing, pupil size switching and double camera pupil monitoring are used to ensure that the patient's fundus image can be presented clearly and reliably. Mobile Platform Module This module is mainly responsible for control of the position of optical module (i.e. up, down, left, right, back and forth movement of the optical module). This includes X, Y, Z axes, which are designed with servo motor and bearing, which are controlled by PCB board in the control module. Power Supply Module Power supply to each module through medical switching power supply. Control Module To enable operators to control the product, understand the working status of the product, observe the patient's condition, and carry out the corresponding inspection work normally. There is a computer system integrated in the product, the input and output function are realized by touch screen display. Chin Rest Module To place the patient's head and keep the patient's eyes stable and easy to observe.
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