BEUDAMED
    Product Code: SHP FDA class 2 21 CFR 870.2380

    Cardiac Amyloidosis Machine Learning-Based Notification Software

    Cardiovascular
    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    SHP
    Device Class
    FDA class 2
    Regulation Number
    870.2380
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Cardiac Amyloidosis machine learning-based notification software employs machine learning techniques to suggest the likelihood of cardiac amyloidosis for further referral or diagnostic follow-up.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K253801 ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)