ELEKTA SOLUTIONS AB

FDA Device Registration & Listing · STOCKHOLM, SE · Registration 3015232217

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015232217
FEI Number
3015232217
Entity Name
ELEKTA SOLUTIONS AB
City/State/Country
STOCKHOLM, SE
Establishment Address
Hagaplan 4, STOCKHOLM 11368, SE
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
ELEKTA AB (Owner Number: 8030893)
Owner / Operator Contact Address
Hagaplan 4, Stockholm, SE-AB SE11368, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K152321
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2018-12-05
JAD System, Therapeutic, X-Ray Radiology Class 2 892.5900 2024-12-13
IXQ Table, Radiographic, Stationary Top Radiology Class 2 892.1980 2004-10-14
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2025-05-16
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
IWB System, Radiation Therapy, Radionuclide Radiology Class 2 892.5750 2024-02-12
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2024-02-12
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-05-16
OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Radiology Class 2 892.1200 2025-05-16
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2025-05-16
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-05-16
JAI Couch, Radiation Therapy, Powered Radiology Class 2 892.5770 2025-05-16
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2025-05-16
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2016-03-03
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2025-05-16
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-05-16
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-05-16
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2023-03-02
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-05-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-05-16
JAI Couch, Radiation Therapy, Powered Radiology Class 2 892.5770 2025-05-09
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-05-16
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2025-05-09
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-05-16
JAD System, Therapeutic, X-Ray Radiology Class 2 892.5900 2024-12-13
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-05-16
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2025-05-16
JAI Couch, Radiation Therapy, Powered Radiology Class 2 892.5770 2025-05-16
OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Radiology Class 2 892.1200 2025-05-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-05-16
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-05-16
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2025-05-16
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-09
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2026-03-03
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2025-05-16
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2025-05-16
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-05-16
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2025-05-16
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2025-05-16
FRZ Device, Patient Transfer, Powered General Hospital Class 2 880.6775 2025-05-16
OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Radiology Class 2 892.1200 2025-05-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-05-16
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
JAI Couch, Radiation Therapy, Powered Radiology Class 2 892.5770 2025-05-16
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2020-10-30
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2025-05-09
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2022-05-18
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2019-08-20
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-09
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2018-10-15
JAD System, Therapeutic, X-Ray Radiology Class 2 892.5900 2024-12-13
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-09
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2026-03-23
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2018-10-15
JAD System, Therapeutic, X-Ray Radiology Class 2 892.5900 2024-12-13
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2025-05-16
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2023-07-13
KPQ System, Simulation, Radiation Therapy Radiology Class 2 892.5840 2023-07-13
IWB System, Radiation Therapy, Radionuclide Radiology Class 2 892.5750 2023-07-13
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-01-07
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-09
QKB Radiological Image Processing Software For Radiation Therapy Radiology Class 2 892.2050 2021-12-03
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2021-12-03
QKB Radiological Image Processing Software For Radiation Therapy Radiology Class 2 892.2050 2025-05-16
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-05-16
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-05-16
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
JAD System, Therapeutic, X-Ray Radiology Class 2 892.5900 2024-12-13
JAI Couch, Radiation Therapy, Powered Radiology Class 2 892.5770 2025-05-16
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2025-05-16
OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Radiology Class 2 892.1200 2025-05-16
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-05-16
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16
FRZ Device, Patient Transfer, Powered General Hospital Class 2 880.6775 2025-05-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-05-16
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2025-05-16
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2023-03-02
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-03-02
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2024-12-13
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2025-05-16

Official Correspondent

No official correspondent registered.

US Agent Details

Thomas Valentine Business: Elekta Inc. Email: Thomas.valentine@elekta.com Phone: (404) 7972537

Related Public Records

Same Entity

ELEKTA AB
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9617016 ELEKTA LIMITED CRAWLEY West Sussex, GB
3032638959 Elekta Inc. San Jose, CA, US
3009894282 ELEKTA BEIJING MEDICAL SYSTEMS CO., LTD Beijing, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K071992 Varian Medical Systems HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) 2007-08-15
K253962 Radformation, Inc. ClearCheck (RADCC V2.7) 2026-04-03
K003779 Arplay Medical S.A. IMMOBILIZATION SYSTEM FOR ENT 2001-07-12
K241174 Carl Zeiss Meditec, AG INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) 2025-01-10
K993675 Nomos Corp. PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM 2000-09-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2019 Varian Medical Systems 2
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019 Varian Medical Systems 2
VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015 N/A 2
Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012 Accuray Incorporated 2
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012 Accuray Incorporated 2
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015232217. Last updated year: 2026. Please use registration number 3015232217 when referencing this establishment in official correspondence.
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