BEUDAMED
    Product Code: PCS FDA class 2 21 CFR 892.1001

    Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

    Radiology

    The Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox is a radiology device intended to present images reflecting magnetic resonance spectra for the determination of liver iron concentration, used as a companion diagnostic to guide treatment with the iron chelator deferasirox. It falls under the Radiology medical specialty and is classified as a Class 2 device under regulation 892.1001, requiring 510(k) premarket notification. This type of imaging aids in monitoring iron overload in patients with conditions such as thalassemia or sickle cell disease. It is not an implant and is not life-sustaining.

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    510(k)s
    3
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    9

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    Basic Information

    Product Code
    PCS
    Device Class
    FDA class 2
    Regulation Number
    892.1001
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    1

    Device Characteristics

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

    Definition

    Intended for diagnostic use to present images that reflect the magnetic resonance spectra for the determination of iron in the liver for any indication where an assessment of liver iron concentration is needed. For non-transfusion-dependent thalassemia (NTDT) patients, is intended as an aid in the assessment of NTDT patients for whom deferasirox therapy is being considered and for monitoring of NTDT patients receiving deferasirox 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
    K213776 LiverSmart
    K182218 FerriSmart Analysis System
    DEN130012 FERRISCAN R2-MRI ANALYSIS SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.