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

    INGENUITY DIGITAL PET/CT

    K Number: K123599 · Decision Jul 12, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    6
    Review Days
    233

    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
    INGENUITY DIGITAL PET/CT
    K Number
    K123599
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Healthcare (Cleveland)
    Date Received
    November 21, 2012
    Decision Date
    July 12, 2013
    Product Code
    KPS
    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
    KPS System, Tomography, Computed, Emission

    Similar 510(k) Clearances

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

    Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family

    FDA 510(k)
    FDA Class 2 ·Radiology

    uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)

    FDA 510(k)
    FDA Class 2 ·Radiology

    uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)

    FDA 510(k)
    FDA Class 2 ·Radiology

    AnyScan 3.0 NM Scanner Family

    FDA 510(k)
    FDA Class 2 ·Radiology

    Cartesion Prime (PCD-1000A/3) V10.21

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

    Other Clearances by Philips Healthcare (Cleveland)

    K Number Device Name
    K133674 PHILIPS IQON SPECTRAL CT
    K131773 BRILLIANCE ICT
    K123576 IMR SOFTWARE APPLICATION
    K113483 ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION
    K103483 INGENUITY TF PET/MR