BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    Leksell GammaPlan

    K Number: K173791 · Decision Feb 9, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    47
    Applicant Total
    35
    Review Days
    57

    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
    Leksell GammaPlan
    K Number
    K173791
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elekta Instrument AB
    Date Received
    December 14, 2017
    Decision Date
    February 9, 2018
    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

    Other Clearances by Elekta Instrument AB

    K Number Device Name
    K190887 Leksell Vantage Stereotactic System
    K173789 Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon
    K171123 Leksell Vantage Stereotactic System
    K160440 Leksell Gamma Knife Icon
    K152558 Leksell Stereotactic System, Injection/ Aspiration Needle Kit
    K151159 Leksell Gamma Knife Perfexion
    K151666 Leksell GammaPlan
    K151561 Leksell Gamma Knife Icon
    K133565 LEKSELL GAMMA KNIFE PERFEXION
    K120811 LEKSELL GAMMA KNIFE PERFEXION
    Search all 35 clearances from Elekta Instrument AB →