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    K Number
    K251368
    Device Name
    FETOLY
    Manufacturer
    Diagnoly
    Date Cleared
    2025-09-12

    (134 days)

    Product Code
    IYN,IYO,QIH
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Radiology (RA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251820
    Device Name
    ViewMateTM Ultrasound System
    Manufacturer
    Shenzhen Mindray Bio-medical Electronics Co., Ltd.
    Date Cleared
    2025-09-12

    (91 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Radiology (RA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250986
    Device Name
    S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
    Manufacturer
    Mevion Medical Systems, Inc.
    Date Cleared
    2025-09-12

    (165 days)

    Product Code
    LHN
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Radiology (RA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250040
    Device Name
    uWS-Angio
    Manufacturer
    Shanghai United Imaging Healthcare Co., Ltd.
    Date Cleared
    2025-09-12

    (247 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Radiology (RA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K243864
    Device Name
    BONX805
    Manufacturer
    BONTECH Co., Ltd.
    Date Cleared
    2025-09-12

    (269 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Radiology (RA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K242314
    Device Name
    Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)
    Manufacturer
    Augment Intelligent Medical System (China) Co., Ltd.
    Date Cleared
    2025-09-11

    (402 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Radiology (RA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251399
    Device Name
    SIGNA™ Sprint
    Manufacturer
    GE Medical Systems, LLC
    Date Cleared
    2025-09-11

    (128 days)

    Product Code
    LNH,LNI,MOS
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Radiology (RA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K244002
    Device Name
    AngioWaveNet
    Manufacturer
    Angiowave Imaging, Inc.
    Date Cleared
    2025-09-10

    (258 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Radiology (RA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251072
    Device Name
    Segmentron Viewer
    Manufacturer
    DGNCT, LLC
    Date Cleared
    2025-09-09

    (155 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Radiology (RA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252477
    Device Name
    Hybrid Viewer (00859873006240)
    Manufacturer
    Hermes Medical Solutions AB
    Date Cleared
    2025-09-09

    (33 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Type
    Special
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Panel :

    Radiology (RA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    Device Description
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