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510(k) Data Aggregation

    K Number
    K260257

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    Device Name
    CO2 Laser System
    Manufacturer
    Sanhe Meditech Co., Ltd.
    Date Cleared
    2026-03-28

    (59 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252360

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    Device Name
    ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
    Manufacturer
    Anumana, Inc.
    Date Cleared
    2026-03-28

    (242 days)

    Product Code
    SAT
    Regulation Number
    870.2380
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252195

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    Device Name
    ARTICOR planner
    Manufacturer
    Artiness S.R.L
    Date Cleared
    2026-03-27

    (256 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K260697

    Validate with FDA (Live)

    Device Name
    VyPlate™ Anterior Cervical Plate System
    Manufacturer
    Vy Spine, LLC
    Date Cleared
    2026-03-27

    (23 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Special
    Panel
    Orthopedic
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K260041

    Validate with FDA (Live)

    Device Name
    MDx-Chex for BCP
    Manufacturer
    Streck, LLC
    Date Cleared
    2026-03-27

    (80 days)

    Product Code
    PMN
    Regulation Number
    866.3920
    Type
    Traditional
    Panel
    Microbiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253595

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    Device Name
    EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
    Manufacturer
    Philips Ultrasound, LLC
    Date Cleared
    2026-03-27

    (129 days)

    Product Code
    IYN,ITX,IYO,OBJ,QIH
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253649

    Validate with FDA (Live)

    Device Name
    Spectral CT Verida Family
    Manufacturer
    Philips Medical Systems Technologies , Ltd.
    Date Cleared
    2026-03-27

    (127 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K254099

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    Device Name
    EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System
    Manufacturer
    Samsung Medison Co., Ltd.
    Date Cleared
    2026-03-27

    (98 days)

    Product Code
    IYN,ITX,IYO,LLZ
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    Device Description
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    K Number
    K252006

    Validate with FDA (Live)

    Device Name
    OTTO™ Disinfecting Cap
    Manufacturer
    Icu Medical, Inc.
    Date Cleared
    2026-03-27

    (273 days)

    Product Code
    QBP
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K260271

    Validate with FDA (Live)

    Device Name
    Strauss Surgical cystoscope, hysteroscope and accessories Instruments
    Manufacturer
    American Medical Endoscopy, Inc.
    Date Cleared
    2026-03-27

    (58 days)

    Product Code
    FAJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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