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

    CURA COLLIMATOR

    K Number: K123893 · Decision Mar 4, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    50
    Applicant Total
    2
    Review Days
    76

    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
    CURA COLLIMATOR
    K Number
    K123893
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cura Medical Technologies, LLC
    Date Received
    December 18, 2012
    Decision Date
    March 4, 2013
    Product Code
    IXI
    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
    IXI Block, Beam-Shaping, Radiation Therapy

    Similar 510(k) Clearances

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

    Ricoh 3D for Healthcare Bolus

    FDA 510(k)
    FDA Class 2 ·Radiology

    VHA Radiotherapy Bolus

    FDA 510(k)
    FDA Class 2 ·Radiology

    VSP Bolus

    FDA 510(k)
    FDA Class 2 ·Radiology

    .DECIMAL PROTON APERTURE

    FDA 510(k)
    FDA Class 2 ·Radiology

    CURA COMPENSATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    .DECIMAL PHOTON BLOCK

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

    Other Clearances by Cura Medical Technologies, LLC

    K Number Device Name
    K131150 CURA COMPENSATOR