BEUDAMED
    Product Code: SDJ FDA class 2 21 CFR 870.2200

    Adjunctive Cardiac Amyloidosis Status Indicator

    Cardiovascular

    An adjunctive cardiac amyloidosis status indicator is a prescription cardiovascular device based on sensor technology or image data that provides information to an interpreting clinician to aid in detecting cardiac amyloidosis, intended for adjunctive use alongside other vital sign parameters and patient information and not intended to independently direct therapy. It is classified as FDA Class II (510(k) required) under regulation 870.2200 in the Cardiovascular specialty, with product code SDJ. The device is not an implant and does not support life-sustaining functions.

    View on FDA
    510(k)s
    3
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    3
    Years Active
    1

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    Basic Information

    Product Code
    SDJ
    Device Class
    FDA class 2
    Regulation Number
    870.2200
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

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

    Definition

    The adjunctive cardiac amyloidosis status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting cardiac amyloidosis. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K250151 Us2.ca
    K243866 InVision Precision Cardiac Amyloid
    K240860 EchoGo Amyloidosis (1.0)

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.