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510(k) Data Aggregation

    K Number
    K251798

    Validate with FDA (Live)

    Device Name
    RCT700
    Manufacturer
    Date Cleared
    2025-11-25

    (166 days)

    Product Code
    Regulation Number
    892.1750
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    RCT700 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway and ENT structure for diagnostic support for adult and pediatric patients. And a model scan is included as an option. Cephalometric image also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment.

    The device is to be operated and used by dentists or other legally qualified heath care professionals

    Device Description

    RCT700 provides 3D computed tomography for scanning hard tissues such as bone and teeth. By rotating the C-arm, which houses a high-voltage generator, an X-ray tube and a detector on each end, CBCT images of dental maxillofacial structures are obtained by recombining data scanned from the same level at different angles. Functionalities include panoramic image scanning for obtaining images of whole teeth, and a cephalometric option for obtaining cephalometric images.
    The software of RCT700 saves the patient and image data and offers an inquiry function, in addition, supports the image generate function intended to obtain images using the RCT700 equipment and various sensors for diagnosis.

    AI/ML Overview

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