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

    JETPACK 2.0

    K Number: K111024 · Decision Apr 21, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    190
    Review Days
    9

    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
    JETPACK 2.0
    K Number
    K111024
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems (Cleveland), Inc.
    Date Received
    April 12, 2011
    Decision Date
    April 21, 2011
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LLZ System, Image Processing, Radiological

    Similar 510(k) Clearances

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

    2D Hip Planning Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    CustoMED Viewer

    FDA 510(k)
    FDA Class 2 ·Radiology

    Helion Viewer Suite

    FDA 510(k)
    FDA Class 2 ·Radiology

    CMN Capillary Function with Virtual Expert for MRI, CT and CBCT

    FDA 510(k)
    FDA Class 2 ·Radiology

    SubtleHD-PET (1.x)

    FDA 510(k)
    FDA Class 2 ·Radiology

    HipGuide (V 1.0.0.0)

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

    Other Clearances by Philips Medical Systems (Cleveland), Inc.

    K Number Device Name
    K171850 Philips CT Big Bore
    K172406 Ingenuity TF
    K162838 Philips iCT CT System
    K163711 IQon Spectral CT
    K170086 Pinnacle Radiation Therapy Planning System
    K160743 Philips Ingenuity CT
    K153444 Philips Multislice CT System with Low Dose CT Lung Cancer
    K130992 PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
    K111336 EBW NM 2.0
    K092747 PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL
    Search all 190 clearances from Philips Medical Systems (Cleveland), Inc. →