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

    OS-2000 OPTICAL SONOGRAPHY SYSTEM

    K Number: K001510 · Decision Nov 30, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    4
    Review Days
    199

    Basic Information

    Device Name
    OS-2000 OPTICAL SONOGRAPHY SYSTEM
    K Number
    K001510
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ADVANCED DIAGNOSTICS, INC.
    Date Received
    May 15, 2000
    Decision Date
    November 30, 2000
    Product Code
    NCS
    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
    NCS System, Imaging, Holography, Acoustic

    Similar 510(k) Clearances

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

    AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)

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

    Other Clearances by ADVANCED DIAGNOSTICS, INC.

    K Number Device Name
    K023037 MID STREAM PREGNANCY TEST
    K013886 AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
    K013291 ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)