BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    ELEKTA SOLUTIONS AB

    Reg #: 3015232217 · FEI: 3015232217 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    100
    Establishment Types
    3
    Classifications
    24

    Registration Details

    Registration Name
    ELEKTA SOLUTIONS AB
    Registration Number
    3015232217
    FEI Number
    3015232217
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Hagaplan 4
    City
    STOCKHOLM
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K183034

    Owner / Operator

    Firm Name
    ELEKTA AB
    Operator Number
    8030893
    Address
    Hagaplan 4
    City
    Stockholm
    State
    SE-AB
    Postal Code
    SE11368
    Country
    SE

    US Agent

    Business Name
    Elekta Inc.
    Contact Name
    Thomas Valentine
    Address
    400 Perimeter Center Terrace, Suite 50
    City
    ATL
    State
    GA
    ZIP
    30346
    Country
    US
    Email
    [email protected]
    Phone
    404 7972537

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE
    System, Therapeutic, X-Ray JAD
    Table, Radiographic, Stationary Top IXQ
    System, Radiation Therapy, Charged-Particle, Medical LHN
    System, Radiation Therapy, Radionuclide IWB
    System, Planning, Radiation Therapy Treatment MUJ
    System, Nuclear Magnetic Resonance Imaging LNH
    Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance OUO
    System, Tomography, Computed, Emission KPS
    System, X-Ray, Tomography, Computed JAK
    Couch, Radiation Therapy, Powered JAI
    Neurological Stereotaxic Instrument HAW
    System, Image Processing, Radiological LLZ
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Angiographic IZI
    Device, Patient Transfer, Powered FRZ
    System, Applicator, Radionuclide, Remote-Controlled JAQ
    System, Simulation, Radiation Therapy KPQ
    Radiological Image Processing Software For Radiation Therapy QKB
    Camera, Scintillation (Gamma) IYX
    Block, Beam-Shaping, Radiation Therapy IXI
    Instrument, Quality-Assurance, Radiologic LHO
    Operating Room Accessories Table Tray FWZ
    Radiological Image Processing Software For Ablation Therapy Planning And Evaluation QTZ

    Proprietary Names

    MOSAIQ Axxent Vaginal Applicator Elekta Unity CT Overlay Unity CT Overlay iBEAM, various Connexion, various The Edge - Scanning Diode Detector, Model 1118 Sun 125c Ionization Chamber Dose Calculator Leksell GammaPlan (LGP) 11.4 Model 1212 3DVH Encompass SRS Headframe ; Encompass MR SRS Headframe Leksell Stereotactic System® Mobile MIM (RT) MIM – Monte Carlo Dosimetry MOSAIQ OIS (Oncology Information System) MIM On Linux QED Diode Detectors, Models 1112-1116 HexaPOD evo RT Couch Top Model 1014 PC Electrometer MIM - Centiloid Scaling Blue Phantom Pt Profiler 2 Model 1174 MIM 5.2 (Brachy) Xoft Axxent Electronic Brachytherapy System Delta4 Phantom+ Mr (PMMA), Delta4 Phantom+ Mr (PW) AlignRT Plus BellySTEP, HeadSTEP, BreastSTEP, ProSTEP, WingSTEP And iCAST MIM – Additional Tracers Qfix® Abdominal/Thoracic Motion Control System,Qfix® Sbrt Solution And Accessories Thermoplastic Masks Monaco RTP System (6.3) Iris Airshuttle Geneva EPIgray Monaco ExacTrac Dynamic (2); ExacTrac Dynamic Surface Leksell Vantage Stereotactic System ScandiDos Delta4 Phantom+ Beamscan BodyFIX System Axxent Cervical Applicator PerFRACTION, Model 1215 Catalyst ExacTrac Dynamic ProKnow DS 2.1 iGUIDE 2.1 Axxent Surface Applicator, Model 710257 myQA iON Clarity System SunCHECK ProKnow DS Octavius I, Octavius II, Octavius III, Octavius 4d Advanced Algorithms For Treatment Management Applications (AATMA) Contour ProtegeAI+ MIM - MRT Dosimetry 3d Scanner, Model 1230 ArcCHECK Xoft Axxent Electronic Brachytherapy System Model 110 XP 1200 Alta Multipurpose Device Elekta Unity MR Linac Xoft Axxent Cervical Applicators kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilizat Sentinel MIM – Y90 Dosimetry Axxent Flexishield Mini Leksell Gamma Knife AQUA Software ThonkQA Waterproof Profiler, Model 1203 Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head Klarity Bolus Xoft Axxent Electronic Brachytherapy System Model 110 ExacTrac Dynamic 1.1.2 MIM - SPECTRA Quant Klarity Vacuum Bag, Klarity Mold Cushion RF-IVD Wireless Dosimeter-Model 1133 Klarity SRS Baseplate, Klarity Promise Baseplate Model 1177 MapCHECK2, Model 1220 ArcCHECK Axxent Radiation Shield - Rigid Active Breathing Coordinator EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elek ThinkQA ed.2 ATLAS INTERVENTION MIM-Thin Client (Mobile) Beamscan Mr MOSAIQ Oncology Informations System Catalyst+, Catalyst HD, Catalyst, Catalyst +HD, Catlayst Tomo, Catalyst PT Monaco RTP System Quality Reports, Model 1216 DoseCHECK ArcCHECK-MR AlignRT Leksell Gamma Knife - Espirit, Leksell Gamma Knife Icon, Leksell Gamma Knife Perfexion IQM Integral Quality Monitor (Also IQM) MIM – Dose Analysis Axxent Balloon Applicator, Model Ab2034, Ab2045, Ab2056, Ab2057e, Ab2067e MIM-Ablation Elekta Synergy, Elekta Infinity, Versa HD, Elekta Harmony/Harmony Pro Fraxion

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device