LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K190856
    Device Name
    SeeFactorCT3
    Manufacturer
    Epica International Inc.
    Date Cleared
    2019-09-20

    (171 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Epica International Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires sequences of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular joint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and upper and lower extremities for use in diagnostic support. The device displays two and three dimensional images for each examined anatomical region. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
    Device Description
    See Factor CT3 is a Diagnostic CBCT (Cone Beam Computed Tomography) device that integrates High Definition Computed Tomography (HDCT) for obtaining High Resolution 3D Volume with 2D High Resolution Scouting, through Dynamic Scouting and Single Pulse Modality.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1