Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K233043
    Device Name
    Smart Scope® CX
    Manufacturer
    Periwinkle Technologies Pvt. Ltd
    Date Cleared
    2024-06-14

    (263 days)

    Product Code
    HEX
    Regulation Number
    884.1630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Periwinkle Technologies Pvt. Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Smart Scope® CX is intended for gynecological examination. It provides a portable means of magnified visualization of the tissues of the vagina, cervix, and external genitalia to aid in diagnosing abnormalities and selecting areas for biopsy. The Net4Medix® application is intended to provide documentation of the field of view of the scope. The Smart Scope® CX camera probe is intended to be inserted into the a speculum by trained medical personnel in hospitals, clinics, and private offices, and is not intended for home use.
    Device Description
    Smart Scope® CX is a handheld, reusable transvaginal digital examination camera designed for use in a hospital or clinical setting. It is intended for close examination and magnified visualization of the external genitalia, vagina, and cervix. The Smart Scope® CX camera probe is equipped with an integrated green and white LED light, which serves to illuminate the object under observation. Additionally, it features a 10X magnification camera, facilitating the capture of color images. Users can switch between the white and green light illumination and zoom in or out to capture images at different working distances by pressing respective buttons in the smart scope probe. By establishing a USB connection between the Smart Scope and a tablet, users can access live images and capture necessary stills using the Net4Medix® application, installed on the tablet. These captured images are then stored directly on the tablet. The Net4Medix® software further enables the creation and management of patient records, visit histories, and seamless integration with the Smart Scope® CX for functions such as image streaming, capture, storage, and assignment to the respective patient records. The Smart Scope® CX is designed and intended to be used only with speculum and it is not intended to come into direct contact with the body. Smart Scope® CX is not a substitute for histopathology and is not a diagnostic test.
    Ask a Question

    Page 1 of 1