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

    Q-Rad Radiographic System with Auto-Tracker Option

    K Number: K151924 · Decision Aug 7, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    355
    Applicant Total
    1
    Review Days
    25

    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
    Q-Rad Radiographic System with Auto-Tracker Option
    K Number
    K151924
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quantum Medical Imaging Divison of Carestream
    Date Received
    July 13, 2015
    Decision Date
    August 7, 2015
    Product Code
    KPR
    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
    KPR System, X-Ray, Stationary

    Similar 510(k) Clearances

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

    DRE Duo

    FDA 510(k)
    FDA Class 2 ·Radiology

    AeroDR TX c02

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector

    FDA 510(k)
    FDA Class 2 ·Radiology

    uDR Arria & uDR Aris

    FDA 510(k)
    FDA Class 2 ·Radiology

    uDR Aurora CX

    FDA 510(k)
    FDA Class 2 ·Radiology

    Definium Tempo Select

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