Data / Medical devices / Sweden / Elekta Solutions AB
Elekta Solutions AB: FDA-registered device maker in Stockholm, Sweden, 93 510(k) clearances
Elekta Solutions AB is registered with the FDA (registration 3015232217) in Stockholm, Sweden. It lists 23 device types. The FDA files 93 510(k) clearances under its listings, the newest dated August 5, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015232217
- Address
- Hagaplan 4, Stockholm, Sweden, 11368
- Owner or operator
- ELEKTA AB (8030893)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- October 14, 2004
- Registered through
- 2027
- Brand names listed
- 3d Scanner, Model 1230, AQUA Software, ATLAS INTERVENTION, Active Breathing Coordinator, AlignRT, AlignRT Plus, Alta Multipurpose Device, ArcCHECK and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 5, 2026 | K261932 | Leksell® Vantage Stereotactic System | HAW | Substantially Equivalent | Elekta Solutions AB | accessdata.fda.gov |
| February 19, 2026 | K252002 | Monaco RTP System (6.3) | MUJ | Substantially Equivalent | Elekta Solutions AB | accessdata.fda.gov |
| January 15, 2026 | K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) | IYE | Substantially Equivalent | Elekta Solutions AB | accessdata.fda.gov |
| October 8, 2025 | K251363 | ProKnow DS | LLZ | Substantially Equivalent | Elekta Solutions AB | accessdata.fda.gov |
| July 2, 2025 | K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion) | IWB | Substantially Equivalent | Elekta Solutions AB | accessdata.fda.gov |
| July 24, 2024 | K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | IYE | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| May 20, 2024 | K233620 | MIM - Centiloid Scaling | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| May 13, 2024 | K232862 | MIM Monte Carlo Dosimetry | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| May 6, 2024 | K232514 | MIM Dose Analysis | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| March 29, 2024 | K233622 | AlignRT Plus | IYE | Substantially Equivalent | Vision Rt, Ltd. | accessdata.fda.gov |
| February 8, 2024 | K232854 | Leksell GammaPlan (LGP) | IWB | Substantially Equivalent | Elekta Solutions AB | accessdata.fda.gov |
| January 18, 2024 | K231573 | ThinkQA (Edition 2) | IYE | Substantially Equivalent | Dosisoft SA | accessdata.fda.gov |
| November 8, 2023 | K231765 | Contour ProtégéAI | QKB | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| May 11, 2023 | K231052 | ExacTrac Dynamic 1.1.2 | IYE | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| March 31, 2023 | K230312 | Iris AirShuttle | IYE | Substantially Equivalent | Qfix | accessdata.fda.gov |
| February 23, 2023 | K223233 | Monaco RTP System | MUJ | Substantially Equivalent | Elekta Solutions AB | accessdata.fda.gov |
| February 23, 2023 | K223229 | MOSAIQ® OIS (Oncology Information System) | IYE | Substantially Equivalent | Elekta Solutions AB | accessdata.fda.gov |
| February 23, 2023 | K223209 | Elekta Unity | IYE | Substantially Equivalent | Elekta Solutions AB | accessdata.fda.gov |
| January 17, 2023 | K223800 | MIM Additional Tracers | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| November 1, 2022 | K220539 | Klarity SRS Baseplate, Klarity Promise Baseplate | IYE | Substantially Equivalent | Klarity Medical & Equipment (GZ) Co., Ltd. | accessdata.fda.gov |
| October 26, 2022 | K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) | IWB | Substantially Equivalent | Elekta Solutions AB | accessdata.fda.gov |
| October 7, 2022 | K220256 | MIM-Ablation | QTZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| May 17, 2022 | K213787 | Monaco RTP System | MUJ | Substantially Equivalent | Elekta Solutions AB | accessdata.fda.gov |
| April 29, 2022 | K220338 | ExacTrac Dynamic | IYE | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| June 11, 2021 | K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD | IYE | Substantially Equivalent | Elekta Limited | accessdata.fda.gov |
| May 14, 2021 | K202747 | Klarity Bolus | IYE | Substantially Equivalent | Klarity Medical & Equipment (GZ) Co., Ltd. | accessdata.fda.gov |
| February 23, 2021 | K202789 | Monaco Rtp System | MUJ | Substantially Equivalent | Elekta Solutions AB | accessdata.fda.gov |
| December 18, 2020 | K203172 | MOSAIQ Oncology Information System | IYE | Substantially Equivalent | Elekta Solutions AB | accessdata.fda.gov |
| July 17, 2020 | K201798 | myQA iON | LHN | Substantially Equivalent | Iba Dosimetry GmbH | accessdata.fda.gov |
| July 16, 2020 | K201272 | Geneva | JAQ | Substantially Equivalent | Nucletron B.V. | accessdata.fda.gov |
| May 7, 2020 | K200435 | Catalyst+, Catalyst+ HD | IYE | Substantially Equivalent | C-Rad Positioning AB | accessdata.fda.gov |
| April 20, 2020 | K200600 | Sentinel | IYE | Substantially Equivalent | C-Rad Positioning AB | accessdata.fda.gov |
| February 28, 2020 | K193243 | Alta Multipurpose Device | IYE | Substantially Equivalent | Qfix | accessdata.fda.gov |
| February 21, 2020 | K191646 | Beamscan MR | IYE | Substantially Equivalent | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | accessdata.fda.gov |
| January 23, 2020 | K191821 | Blue Phantom PT | LHN | Substantially Equivalent | Iba Dosimetry GmbH | accessdata.fda.gov |
| September 25, 2019 | K192102 | Thermoplastic Masks | IYE | Substantially Equivalent | Aktina Medical Corporation | accessdata.fda.gov |
| August 1, 2019 | K190887 | Leksell Vantage Stereotactic System | HAW | Substantially Equivalent | Elekta Instrument AB | accessdata.fda.gov |
| March 19, 2019 | K190379 | MIM on Linux | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| January 2, 2019 | K182855 | ProKnow DS | LLZ | Substantially Equivalent | Proknow, LLC | accessdata.fda.gov |
| December 18, 2018 | K182624 | MIM - MRT Dosimetry | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| December 4, 2018 | K183034 | MOSAIQ Oncology Information System | IYE | Substantially Equivalent | Elekta, Inc. | accessdata.fda.gov |
| October 4, 2018 | K182189 | Encompass SRS Headframe ; Encompass MR SRS Headframe | IYE | Substantially Equivalent | Qfix | accessdata.fda.gov |
| June 22, 2018 | K180815 | MIM - SPECTRA Quant | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| March 13, 2018 | K180106 | ThinkQA | IYE | Substantially Equivalent | Dosisoft | accessdata.fda.gov |
| November 21, 2017 | K172218 | MIM Y90 Dosimetry | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| October 25, 2017 | K170307 | SunCHECK | IYE | Substantially Equivalent | Sun Nuclear Corporation | accessdata.fda.gov |
| October 20, 2017 | K160405 | OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D | IYE | Substantially Equivalent | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | accessdata.fda.gov |
| July 11, 2017 | K171133 | Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories | IYE | Substantially Equivalent | Qfix | accessdata.fda.gov |
| May 19, 2017 | K161807 | BEAMSCAN | IYE | Substantially Equivalent | Ptw-Freiburg Physikalisch Technische-Werksraetten | accessdata.fda.gov |
| October 20, 2016 | K162629 | IQM Integral Quality Monitor (also IQM) | IYE | Substantially Equivalent | Irt Systems | accessdata.fda.gov |
| September 16, 2016 | K161946 | DoseCHECK | IYE | Substantially Equivalent | Sun Nuclear Corporation | accessdata.fda.gov |
| June 14, 2016 | K160627 | Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution | IYE | Substantially Equivalent | Qfix | accessdata.fda.gov |
| May 13, 2016 | K160057 | ArcCHECK-MR | IYE | Substantially Equivalent | Sun Nuclear Corporation | accessdata.fda.gov |
| April 25, 2016 | K151913 | MIM-Thin Client (mobile) | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| March 2, 2016 | K152558 | Leksell Stereotactic System, Injection/ Aspiration Needle Kit | HAW | Substantially Equivalent | Elekta Instrument AB | accessdata.fda.gov |
| February 25, 2016 | K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200 | JAD | Substantially Equivalent | Icad, Inc. | accessdata.fda.gov |
| December 4, 2015 | K152321 | kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening | IYE | Substantially Equivalent | Qfix | accessdata.fda.gov |
| November 20, 2015 | K142617 | ArcCHECK | IYE | Substantially Equivalent | Sun Nuclear Corporation | accessdata.fda.gov |
| May 20, 2015 | K150848 | Dose Calculator | IYE | Substantially Equivalent | Sun Nuclear Corporation | accessdata.fda.gov |
| May 15, 2015 | K151097 | Active Breathing Coordinator | IYE | Substantially Equivalent | Aktina Medical Corporation | accessdata.fda.gov |
| March 4, 2015 | K143485 | iGuide 2.1 | IYE | Substantially Equivalent | Medical Intelligence Medizintechnik GmbH | accessdata.fda.gov |
| December 5, 2014 | K142431 | WaterProof PROFILER | IYE | Substantially Equivalent | Sun Nuclear Corporation | accessdata.fda.gov |
| December 5, 2014 | K142142 | QUALITY REPORTS | IYE | Substantially Equivalent | Sun Nuclear Corporation | accessdata.fda.gov |
| September 26, 2014 | K141800 | PERFRACTION | IYE | Substantially Equivalent | Sun Nuclear Corporation | accessdata.fda.gov |
| September 5, 2014 | K141343 | AXXENT CERVICAL APPLICATOR | JAD | Substantially Equivalent | Icad, Inc. | accessdata.fda.gov |
| November 1, 2013 | K132124 | KLARITY VACUUM BAG, KLARITY MOLD CUSHION | IYE | Substantially Equivalent | Klarity Medical Products, LLC | accessdata.fda.gov |
| August 21, 2013 | K131862 | 3DVH | IYE | Substantially Equivalent | Sun Nuclear Corporation | accessdata.fda.gov |
| August 20, 2013 | K131466 | MAPCHECK2, ARCCHECK | IYE | Substantially Equivalent | Sun Nuclear Corporation | accessdata.fda.gov |
| February 27, 2013 | K123442 | XOFT AXXENT CERVICAL APPLICATORS | JAQ | Substantially Equivalent | Icad, Inc. | accessdata.fda.gov |
| January 17, 2013 | K122951 | XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 | JAD | Substantially Equivalent | Icad, Inc. | accessdata.fda.gov |
| June 20, 2012 | K121530 | BODYFIX SYSTEM | IYE | Substantially Equivalent | Medical Intelligence Medizintechnik GmbH | accessdata.fda.gov |
| February 27, 2012 | K113276 | CATALYST | IYE | Substantially Equivalent | C-Rad Positioning AB | accessdata.fda.gov |
| February 8, 2012 | K112723 | EPIGRAY | MUJ | Substantially Equivalent | Dosisoft SA | accessdata.fda.gov |
| January 25, 2012 | K112981 | SUN 125C IONIZATION CHAMBER | LHN | Substantially Equivalent | Sun Nuclear Corp. | accessdata.fda.gov |
| December 2, 2011 | K112930 | MOBILE MIM | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| November 22, 2011 | K112210 | FRAXION | IYE | Substantially Equivalent | Medical Intelligence Medizintechnik GmbH | accessdata.fda.gov |
| July 20, 2011 | K111299 | AXXENT RADIATION SHIELD - RIGID | JAD | Substantially Equivalent | Xoft, an Icad Company | accessdata.fda.gov |
| February 18, 2011 | K103576 | MIM 5.2 (BRACHY) | LLZ | Substantially Equivalent | Mim Software, Inc. | accessdata.fda.gov |
| October 1, 2010 | K101992 | 3D SCANNER, MODEL 1230 | IYE | Substantially Equivalent | Sun Nuclear Corp. | accessdata.fda.gov |
| September 15, 2009 | K092019 | MODEL 1014 PC ELECTROMETER | IYE | Substantially Equivalent | Sun Nuclear Corp. | accessdata.fda.gov |
| July 16, 2009 | K090914 | AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E | JAD | Unknown | Xoft, Inc. | accessdata.fda.gov |
| June 23, 2009 | K090417 | AXXENT FLEXISHIELD MINI | IXI | Substantially Equivalent | Xoft, Inc. | accessdata.fda.gov |
| February 11, 2009 | K083734 | AXXENT SURFACE APPLICATOR, MODEL 710257 | JAD | Substantially Equivalent | Xoft, Inc. | accessdata.fda.gov |
| July 21, 2008 | K081218 | BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST | IYE | Substantially Equivalent | It-V Medizintechnik, GmbH | accessdata.fda.gov |
| May 9, 2008 | K072616 | AXXENT VAGINAL APPLICATOR | JAD | Substantially Equivalent | Xoft, Inc. | accessdata.fda.gov |
| February 29, 2008 | K072683 | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM | JAD | Unknown | Xoft, Inc. | accessdata.fda.gov |
| October 25, 2007 | K072898 | HEXAPOD EVO RT COUCH TOP | JAI | Substantially Equivalent | Medical Intelligence Medizintechnik GmbH | accessdata.fda.gov |
| November 22, 2006 | K063021 | PROFILER 2 | IYE | Substantially Equivalent | Sun Nuclear Corp. | accessdata.fda.gov |
| January 6, 2006 | K052682 | ALIGNRT | IYE | Substantially Equivalent | Vision RT Limited | accessdata.fda.gov |
| December 22, 2005 | K050843 | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM | JAD | Unknown | Xoft, Inc. | accessdata.fda.gov |
| July 27, 2005 | K051921 | THE EDGE DETECTOR, MODEL 1118 | IYE | Substantially Equivalent | Sun Nuclear Corp. | accessdata.fda.gov |
| July 26, 2001 | K011332 | RF-IVD WIRELESS DOSIMETER-MODEL 1133 | IYE | Substantially Equivalent | Sun Nuclear Corp. | accessdata.fda.gov |
| June 6, 2001 | K011466 | QED DIODE DETECTORS, MODELS 1112-1116 | LNH | Substantially Equivalent | Sun Nuclear Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 17, 2025 | 97562 | Class II | Ongoing | MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3 | When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule. | accessdata.fda.gov |
| September 28, 2021 | 88771 | Class II | Terminated | Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093. | There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter. | accessdata.fda.gov |
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Updated August 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.