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

    R2 BREAST IMAGING WORKSTATION

    K Number: K051743 · Decision Jul 25, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    5
    Review Days
    26

    Basic Information

    Device Name
    R2 BREAST IMAGING WORKSTATION
    K Number
    K051743
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    R2 TECHNOLOGY, INC.
    Date Received
    June 29, 2005
    Decision Date
    July 25, 2005
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    LLZ System, Image Processing, Radiological

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    Other Clearances by R2 TECHNOLOGY, INC.

    K Number Device Name
    K050667 R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE
    K041380 IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR
    K040028 CA-1500
    K023003 IMAGECHECKER-CT WORKSTATION