BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC

    K Number: K972925 · Decision Dec 5, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    148
    Registration Numbers
    148
    Same Product Code
    141
    Applicant Total
    2
    Review Days
    119

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    Basic Information

    Device Name
    ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC
    K Number
    K972925
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.2020
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Access Radiology Corp.
    Date Received
    August 8, 1997
    Decision Date
    December 5, 1997
    Product Code
    LMD
    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
    LMD System, Digital Image Communications, Radiological

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    Other Clearances by Access Radiology Corp.

    K Number Device Name
    K954691 ACCESS RADIOLOGY TELERADIOLOGY IMAGE ACQUISITION & DISTRIBUTION SYSTEM