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510(k) Data Aggregation

    K Number
    K252863

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-19

    (101 days)

    Product Code
    Regulation Number
    892.5050
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253733

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-19

    (25 days)

    Product Code
    Regulation Number
    870.1425
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252071

    Validate with FDA (Live)

    Date Cleared
    2025-12-18

    (170 days)

    Product Code
    Regulation Number
    892.5060
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253839

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-17

    (16 days)

    Product Code
    Regulation Number
    866.3983
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252120

    Validate with FDA (Live)

    Date Cleared
    2025-12-12

    (158 days)

    Product Code
    Regulation Number
    886.1120
    Reference & Predicate Devices
    N/A
    Predicate For
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252785

    Validate with FDA (Live)

    Date Cleared
    2025-12-12

    (101 days)

    Product Code
    Regulation Number
    872.3275
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250743

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-05

    (269 days)

    Product Code
    Regulation Number
    N/A
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252067

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-05

    (157 days)

    Product Code
    Regulation Number
    888.3358
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251657

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-05

    (189 days)

    Product Code
    Regulation Number
    868.5905
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    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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