BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK

    K Number: K133848 · Decision Jun 25, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    6
    Review Days
    189

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    Basic Information

    Device Name
    RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK
    K Number
    K133848
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Heartvista, Inc.
    Date Received
    December 18, 2013
    Decision Date
    June 25, 2014
    Product Code
    LNH
    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
    LNH System, Nuclear Magnetic Resonance Imaging

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    Other Clearances by Heartvista, Inc.

    K Number Device Name
    K212233 RTHawk, HeartVista Cardiac Package
    K183274 RTHawk, HeartVista Cardiac Package
    K170090 RTHawk, HeartVista Cardiac Package
    K153740 RTHawk, HeartVista Cardiac Package
    K142997 RTHawk, HeartVista Workstation with RTHawk