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

    CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGING

    K Number: K953475 · Decision Oct 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    120
    Applicant Total
    13
    Review Days
    75

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    Basic Information

    Device Name
    CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGING
    K Number
    K953475
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2040
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The DU Pont Co.
    Date Received
    July 24, 1995
    Decision Date
    October 7, 1995
    Product Code
    LMC
    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
    LMC Camera, Multi Format, Radiological

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    Other Clearances by The DU Pont Co.

    K Number Device Name
    K953477 MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGING
    K952891 CRONEX LOW ABSORPTION CASSETTE
    K945125 DUPONT ACA VANCOMYCIN (VANC) METHOD
    K943704 LIPASE CALIBRATOR
    K900492 LABELING CHANGE - VIASPAN(TM) (BELZER UW)
    K885259 ACA THYRONINE UPTAKE (TU E) METHOD
    K885258 ACA THYROXINE (T4 E) METHOD
    K884700 ANALYST THYROXINE (T4) ROTOR
    K884169 DU PONT ANALYST THYROID ROTOR
    K884168 ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA.
    Search all 13 clearances from The DU Pont Co. →