FDA.report

ELEKTA SOLUTIONS AB

Matched from indexed company URL: Elekta Solutions AB

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30152322173015232217ELEKTA SOLUTIONS AB1N2026-01-01Hagaplan 4 STOCKHOLM SE 11368

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2287501639520591K984328LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001IWB1999-05-21
2287501569355661K983678ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLEJAI1999-01-15
2287501811546542K981535FOCUS PILOT CONTOURING WORKSTATIONIYE1999-04-02
2287501099994825K981313SEQUENCERIYE1998-07-09
2287501836692040K973936FOCUS RTP SYSTEMIYE1998-06-01
2287501891087148K972398STEALTHSTATION PASSIVE INSTRUMENT OPTIONHAW1997-09-16
2287501597299569K963624PHILIPS SLI SERIES LINEAR ACCELERATORIYE1996-12-06
2287502070378980K915691FOCUS RTPMUJ1995-02-16
2287501547451335K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)IYE2026-01-15
2287501445561414K252002Monaco RTP System (6.3)MUJ2026-02-19
2287501990199030K251363ProKnow DSLLZ2025-10-08
2287502022319124K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)IWB2025-07-02
2287501766532234K240431ExacTrac Dynamic (2.0); ExacTrac Dynamic SurfaceIYE2024-07-24
2287501210967543K233622AlignRT PlusIYE2024-03-29
2287501269555569K233620MIM - Centiloid ScalingLLZ2024-05-20
2287501092591533K232862MIM – Monte Carlo DosimetryLLZ2024-05-13
2287502071122160K232854Leksell GammaPlan (LGP)IWB2024-02-08
2287501623887835K232514MIM – Dose AnalysisLLZ2024-05-06
2287501929938912K231765Contour ProtégéAIQKB2023-11-08
2287501245466689K231573ThinkQA (Edition 2)IYE2024-01-18
2287501302231386K231052ExacTrac Dynamic 1.1.2IYE2023-05-11
2287501551746349K230312Iris AirShuttle™IYE2023-03-31
2287501801673795K223800MIM – Additional TracersLLZ2023-01-17
2287501831309144K223233Monaco RTP SystemMUJ2023-02-23
2287501600704454K223229MOSAIQ® OIS (Oncology Information System)IYE2023-02-23
2287501585500942K223209Elekta UnityIYE2023-02-23
2287501974431319K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)IWB2022-10-26
2287501227868125K220539Klarity SRS Baseplate, Klarity Promise BaseplateIYE2022-11-01
2287501081133366K220338ExacTrac DynamicIYE2022-04-29
2287502067186016K220256MIM-AblationQTZ2022-10-07
2287501366284427K213787Monaco RTP SystemMUJ2022-05-17
2287501692876140K212218Advanced Algorithms for Treatment Management Applications (AATMA)QKB2021-10-25
2287501539201169K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDIYE2021-06-11
2287501820851882K203172MOSAIQ Oncology Information SystemIYE2020-12-18
2287501630969127K202789Monaco Rtp SystemMUJ2021-02-23
2287501029381389K202747Klarity BolusIYE2021-05-14
2287501033717238K201798myQA iONLHN2020-07-17
2287501802704728K201272GenevaJAQ2020-07-16
2287501945489547K200600SentinelIYE2020-04-20
2287502030647118K200435Catalyst+, Catalyst+ HDIYE2020-05-07
2287501493487311K193243Alta Multipurpose DeviceIYE2020-02-28
2287502039029779K192102Thermoplastic MasksIYE2019-09-25
2287501698063668K191821Blue Phantom PTLHN2020-01-23
2287501607990314K191646Beamscan MRIYE2020-02-21
2287501557209792K190887Leksell Vantage Stereotactic SystemHAW2019-08-01
2287501647589330K190379MIM on LinuxLLZ2019-03-19
2287501989321468K183606Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)IYE2019-04-08
2287501129358406K183037Monaco RTP SystemMUJ2018-12-04
2287501550189801K183034MOSAIQ Oncology Information SystemIYE2018-12-04
2287501550189801K183034MOSAIQ Oncology Information SystemIYE2018-12-04
2287501851715383K182855ProKnow DSLLZ2019-01-02
2287501254530734K182624MIM - MRT DosimetryLLZ2018-12-18
2287501221463851K182189Encompass SRS Headframe ; Encompass MR SRS HeadframeIYE2018-10-04
2287502015242178K182076Elekta UnityIYE2018-12-04
2287501429991259K180815MIM - SPECTRA QuantLLZ2018-06-22
2287501288018470K180106ThinkQAIYE2018-03-13
2287501769736125K173791Leksell GammaPlanIWB2018-02-09
2287501611158319K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconIWB2018-03-30
2287501132755878K172218MIM – Y90 DosimetryLLZ2017-11-21
2287501221404895K171133Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and AccessoriesIYE2017-07-11
2287501110230816K171123Leksell Vantage Stereotactic SystemHAW2017-09-15
2287501684865335K170307SunCHECKIYE2017-10-25
2287501138306156K162629IQM Integral Quality Monitor (also IQM)IYE2016-10-20
2287501977438752K161946DoseCHECKIYE2016-09-16
2287501408323742K161807BEAMSCANIYE2017-05-19
2287501132897445K161688Advanced Gynecological ApplicatorJAQ2017-01-27
2287501295851053K160627Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solutionIYE2016-06-14
2287501377537470K160440Leksell Gamma Knife IconIWB2016-04-20
2287501046953098K160405OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4DIYE2017-10-20
2287501313956032K160057ArcCHECK-MRIYE2016-05-13
2287502059241467K153570Axxent Electronic Brachytherapy System Model 110 XP 1200JAD2016-02-25
2287501581399336K153011iViewDose R1.0IYE2015-12-11
2287501299668840K152558Leksell Stereotactic System, Injection/ Aspiration Needle KitHAW2016-03-02
2287501299668840K152558Leksell Stereotactic System, Injection/ Aspiration Needle KitHAW2016-03-02
2287501809410908K152321kVue 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 openingIYE2015-12-04
2287501323562830K151913MIM-Thin Client (mobile)LLZ2016-04-25
2287501603264081K151666Leksell GammaPlanMUJ2015-09-03
2287501317087510K151561Leksell Gamma Knife IconIWB2015-08-04
2287501024632609K151233MonacoMUJ2015-07-07
2287501384258098K151180ScandiDos Delta4 Phantom+IYE2015-08-19
2287501855211004K151159Leksell Gamma Knife PerfexionIWB2015-10-29
2287501617100297K151097Active Breathing CoordinatorIYE2015-05-15
2287501046870663K150848Dose CalculatorIYE2015-05-20
2287501966579103K143485iGuide 2.1IYE2015-03-04
2287501537380166K142617ArcCHECKIYE2015-11-20
2287501543585869K142431WaterProof PROFILERIYE2014-12-05
2287501146165030K142142QUALITY REPORTSIYE2014-12-05
2287501896439933K141855CLARITYIYE2014-10-08
2287501041834471K141800PERFRACTIONIYE2014-09-26
2287501814050539K141572MOSAIQ ONCOLOGY INFORMATION SYSTEMIYE2014-09-05
2287502020385620K141343AXXENT CERVICAL APPLICATORJAD2014-09-05
2287501397446106K132971MONACOMUJ2013-11-20
2287501810641834K132124KLARITY VACUUM BAG, KLARITY MOLD CUSHIONIYE2013-11-01
2287501180208465K131965XVI R5.0IYE2013-09-25
2287501729724182K1318623DVHIYE2013-08-21
2287502045972042K131466MAPCHECK2, ARCCHECKIYE2013-08-20
2287501909958182K123808AGILITYIYE2013-04-04
2287501920503457K123442XOFT AXXENT CERVICAL APPLICATORSJAQ2013-02-27
2287501495688786K123230MOSAIQ ONCOLOGY INFORMATION SYSTEMIYE2012-12-12
2287501170595371K122951XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110JAD2013-01-17
2287501656784772K121530BODYFIX SYSTEMIYE2012-06-20
2287501656784772K121530BODYFIX SYSTEMIYE2012-06-20
2287501624742611K121328AGILITYIYE2012-06-12
2287501763623294K120811LEKSELL GAMMA KNIFE PERFEXIONIWB2012-05-24
2287501845121494K120067MOSAIQ ONCOLOGY INFORMATION SYSTEMIYE2012-02-28
2287501913894879K113276CATALYSTIYE2012-02-27
2287501856463132K112981SUN 125C IONIZATION CHAMBERLHN2012-01-25
2287501541518861K112930MOBILE MIMLLZ2011-12-02
2287501109996370K112723EPIGRAYMUJ2012-02-08
2287501284874210K112613INTEGRITY(TM)IYE2011-12-16
2287501854862923K112210FRAXIONIYE2011-11-22
2287501854862923K112210FRAXIONIYE2011-11-22
2287501201108690K111676APEXIXI2011-09-30
2287501224396116K111299AXXENT RADIATION SHIELD - RIGIDJAD2011-07-20
2287501729413360K110730MONACO RTP SYSTEMMUJ2011-06-24
2287501297441854K103576MIM 5.2 (BRACHY)LLZ2011-02-18
2287501114050655K103093LEKSELL GAMMAPLANMUJ2010-12-21
2287501306159016K102216XIO RTP SYSTEMMUJ2010-10-01
2287501350886122K1019923D SCANNER, MODEL 1230IYE2010-10-01
2287501085605788K100115XVI R4.5IYE2010-03-10

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
IYE742026-01-15
MUJ232026-02-19
IWB152025-07-02
HAW152019-08-01
LLZ132025-10-08
JAD92016-02-25
LHN42020-07-17
JAQ32020-07-16
JAI32007-10-25
QKB22023-11-08
IXI22011-09-30
QTZ12022-10-07
LNH12001-06-06

PMN

GUDID

Monaco

2026-03-20

Elekta Solutions AB

AQUA

2025-12-10

Elekta Solutions AB

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