FDA.reportPublic FDA data

ELEKTA, INC

Matched from indexed company URL: Elekta, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10378311037831ELEKTA, INC1Y2026-01-01400 Perimeter Center Ter Ne Ste 50 Atlanta GA US 30346
96121863002806883Elekta Instrument AB1N2026-01-01Hagaplan 4 Stockholm SE 11368
30098942823009894282ELEKTA BEIJING MEDICAL SYSTEMS CO., LTD1N2026-01-01No. 21, Chuang Xin Road, Science and Technology Park Changping District Beijing CN 102200
30152322173015232217ELEKTA SOLUTIONS AB1N2026-01-01Hagaplan 4 STOCKHOLM SE 11368
30326389593032638959Elekta Inc.1N2026-01-01101 Nicholson Ln San Jose CA US 95134
19376491937649Elekta, Inc.1N2020-04-251450 Beale Street, Suite 205 Saint Charles MO US 63303
29503471000123805Elekta, INC.1N2020-04-25100 Mathilda Pl Fl 5 SUNNYVALE CA US 94086
30047475353004747535ELEKTA LTD.1N2020-04-252050 BLEURY, SUITE 200 MONTREAL Quebec CA H3A 2J5
30083177223008317722ELEKTA LTD.1N2020-04-25555 Richmond Street West, Suite 1001 Toronto Ontario CA M5V3B1

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07340048302395Leksell Stereotactic System - QUICK FIXATION SCREW L=45 MM+1(855)693-5358info.america@elekta.com
07340048305303Leksell Stereotactic System - ARC CARRIER+1(855)693-5358info.america@elekta.com
07340201500118Monaco - Monaco 6.3+1(855)693-5358info.america@elekta.com
07340201502136Leksell GammaPlan - Leksell GammaPlan 11.48556935358info.america@elekta.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
958021639520591K984328LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001IWB1999-05-21
2287501639520591K984328LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001IWB1999-05-21
2287501569355661K983678ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLEJAI1999-01-15
915611811546542K981535FOCUS PILOT CONTOURING WORKSTATIONIYE1999-04-02
2287501811546542K981535FOCUS PILOT CONTOURING WORKSTATIONIYE1999-04-02
107521099994825K981313SEQUENCERIYE1998-07-09
2287501099994825K981313SEQUENCERIYE1998-07-09
915611836692040K973936FOCUS RTP SYSTEMIYE1998-06-01
2287501836692040K973936FOCUS RTP SYSTEMIYE1998-06-01
2287501891087148K972398STEALTHSTATION PASSIVE INSTRUMENT OPTIONHAW1997-09-16
2287501597299569K963624PHILIPS SLI SERIES LINEAR ACCELERATORIYE1996-12-06
915612070378980K915691FOCUS RTPMUJ1995-02-16
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
958021557209792K190887Leksell Vantage Stereotactic SystemHAW2019-08-01
2287501557209792K190887Leksell Vantage Stereotactic SystemHAW2019-08-01
2287501647589330K190379MIM on LinuxLLZ2019-03-19
915611293844943K190178Monaco RTP SystemMUJ2019-03-29
2287501989321468K183606Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)IYE2019-04-08
915611129358406K183037Monaco RTP SystemMUJ2018-12-04
2287501129358406K183037Monaco RTP SystemMUJ2018-12-04
107521550189801K183034MOSAIQ Oncology Information SystemIYE2018-12-04
2287501550189801K183034MOSAIQ Oncology Information SystemIYE2018-12-04
915611851715383K182855ProKnow DSLLZ2019-01-02
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
958021769736125K173791Leksell GammaPlanIWB2018-02-09
2287501769736125K173791Leksell GammaPlanIWB2018-02-09
958021611158319K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconIWB2018-03-30
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
958021110230816K171123Leksell Vantage Stereotactic SystemHAW2017-09-15
2287501110230816K171123Leksell Vantage Stereotactic SystemHAW2017-09-15
2287501684865335K170307SunCHECKIYE2017-10-25
2287501138306156K162629IQM Integral Quality Monitor (also IQM)IYE2016-10-20
2287501977438752K161946DoseCHECKIYE2016-09-16
2287501408323742K161807BEAMSCANIYE2017-05-19
107491132897445K161688Advanced Gynecological ApplicatorJAQ2017-01-27
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
958021377537470K160440Leksell Gamma Knife IconIWB2016-04-20
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
958021299668840K152558Leksell 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
958021603264081K151666Leksell GammaPlanMUJ2015-09-03
2287501603264081K151666Leksell GammaPlanMUJ2015-09-03
958021317087510K151561Leksell Gamma Knife IconIWB2015-08-04
2287501317087510K151561Leksell Gamma Knife IconIWB2015-08-04
915611024632609K151233MonacoMUJ2015-07-07
2287501024632609K151233MonacoMUJ2015-07-07
2287501384258098K151180ScandiDos Delta4 Phantom+IYE2015-08-19
958021855211004K151159Leksell Gamma Knife PerfexionIWB2015-10-29
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
635351581883197K141855CLARITYIYE2014-10-08
2287501896439933K141855CLARITYIYE2014-10-08
2287501041834471K141800PERFRACTIONIYE2014-09-26
107521814050539K141572MOSAIQ ONCOLOGY INFORMATION SYSTEMIYE2014-09-05
2287501814050539K141572MOSAIQ ONCOLOGY INFORMATION SYSTEMIYE2014-09-05
2287502020385620K141343AXXENT CERVICAL APPLICATORJAD2014-09-05
915611397446106K132971MONACOMUJ2013-11-20
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

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYE852026-01-15
MUJ422026-02-19
HAW262019-08-01
IWB252025-07-02
LLZ142025-10-08
JAD92016-02-25
LHN52020-07-17
JAQ42020-07-16
JAI32007-10-25
QKB22023-11-08
IXI22011-09-30
QTZ12022-10-07
LNH12001-06-06

PMN#

APEX

2011-09-30

Elekta Limited

89 records. Showing 1-40. Next

GUDID#

94 records. Showing 1-40. Next