BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    MEDICAL IMAGE DIGITIZER, MODEL 2908

    K Number: K033637 · Decision Dec 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    60
    Applicant Total
    3
    Review Days
    28

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MEDICAL IMAGE DIGITIZER, MODEL 2908
    K Number
    K033637
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2030
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Array Corp.
    Date Received
    November 19, 2003
    Decision Date
    December 17, 2003
    Product Code
    LMA
    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
    LMA Digitizer, Image, Radiological

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LMA), ordered by most recent decision date.

    DICOM VIDEO

    FDA 510(k)
    FDA Class 2 ·Radiology

    TELERADPRO EDGE; TELERADPRO EDGE HD-CCD

    FDA 510(k)
    FDA Class 2 ·Radiology

    DIAGNOSTICPRO EDGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    TELERADPRO

    FDA 510(k)
    FDA Class 2 ·Radiology

    VIDAR DENTAL FILM DIGITIZER

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI-6000 MEDICAL IMAGE DIGITIZER

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by Array Corp.

    K Number Device Name
    K063424 FILM DIGITZER, MODEL 2908 MAMMO PRO
    K982785 FILM DIGITIZER MODEL 2905