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

    MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM)

    K Number: K041125 · Decision Dec 30, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    47
    Applicant Total
    1
    Review Days
    244

    Basic Information

    Device Name
    MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM)
    K Number
    K041125
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    MASEP MED SCIENCE & TECH. DEVELOPMENT (SHENZHEN) C
    Date Received
    April 30, 2004
    Decision Date
    December 30, 2004
    Product Code
    IWB
    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
    IWB System, Radiation Therapy, Radionuclide

    Similar 510(k) Clearances

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

    Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Leksell GammaPlan (LGP)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)

    FDA 510(k)
    FDA Class 2 ·Radiology

    TaiChiC

    FDA 510(k)
    FDA Class 2 ·Radiology

    Akesis Galaxy RTi

    FDA 510(k)
    FDA Class 2 ·Radiology

    Akesis Galaxy RTx

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