BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    Fetal EchoScan

    K Number: K242342 · Decision Nov 14, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    21
    Applicant Total
    5
    Review Days
    99

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    Basic Information

    Device Name
    Fetal EchoScan
    K Number
    K242342
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2060
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brightheart
    Date Received
    August 7, 2024
    Decision Date
    November 14, 2024
    Product Code
    POK
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

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    Other Clearances by Brightheart

    K Number Device Name
    K252294 Fetal EchoScan (v1.2)
    K251456 BrightHeart View Classifier
    K243684 BrightHeart View Classifier
    K251071 Fetal EchoScan (v1.1)