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510(k) Data Aggregation

    K Number
    K230734
    Device Name
    Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)
    Manufacturer
    Precision Healing LLC
    Date Cleared
    2023-12-05

    (264 days)

    Product Code
    QJF, FXN, OCR
    Regulation Number
    878.4550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Precision Healing LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MSI is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds to: · View and digitally record images of a wound. · Measure and digitally record the size of a wound. - · View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. · View and digitally record thermal images of a wound. The MSI does not diagnose or treat skin wounds.
    Device Description
    The MSI Kit includes the following: the MSI, a Universal Serial Bus (USB-C) cable, a wall adapter, and a carrying case. The MSI captures and processes optical data of an imaged wound. The MSI consists of three imaging modalities: white light, autofluorescence and thermal. The MSI has 395nm excitation LEDs for autofluorescence imaging, a sensor for measuring distance to the wound, and a thermal sensor for capturing temperature gradients. The MSI is powered by an onboard rechargeable battery and has a USB-C connection for uploading images to a computer. The manual provides users of the MSI with detailed instructions for proper use, maintenance, and storage.
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