Elekta L T D

FDA Filings

This page includes the latest FDA filings for Elekta L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3008317722
FEI Number3008317722
NameELEKTA LTD.
Owner & OperatorELEKTA AB
Contact AddressKUNGSTENSGATAN 18 Box 7593
STOCKHOLM SE-AB Stockholms lan [SE-01] SE10393 SE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address555 Richmond Street West, Suite 1001
Toronto Ontario, M5V3B1 CA
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number9617016
FEI Number3002806900
NameELEKTA LIMITED
Owner & OperatorELEKTA AB
Contact AddressKUNGSTENSGATAN 18 Box 7593
STOCKHOLM SE-AB Stockholms lan [SE-01] SE10393 SE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressFLEMING WAY
CRAWLEY West Sussex, RH10 9RR GB
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



Registration Number3004747535
FEI Number3004747535
NameELEKTA LTD.
Owner & OperatorELEKTA Instrument AB
Contact AddressKungstensgatan 18
Stockholm SE-AB Stockholms lan [SE-01] 11357 SE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2050 BLEURY, SUITE 200
MONTREAL Quebec, H3A 2J5 CA
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
ELEKTA LIMITED
Elekta Unity 2021-12-08
ELEKTA LIMITED
Elekta Unity 2021-12-08
ELEKTA LIMITED
Elekta Unity 2021-12-08
ELEKTA LIMITED
Elekta Unity 2021-12-08
Elekta Limited
Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD2021-06-11
Elekta Ltd
Clarity® 2020-06-29
ELEKTA LIMITED [ELEKTA AB]
Elekta Unity2020-02-26
ELEKTA LIMITED [ELEKTA AB]
Elekta Synergy Platform, Synergy, Infinity, Versa HD2020-02-26
ELEKTA LIMITED
Integrity™ 2020-01-20
Elekta Limited
Elekta Unity2019-12-05
Elekta Limited
Synergy Platform, Synergy, Infinity, VersaHD2019-11-22
ELEKTA LTD. [ELEKTA AB]
AQUA Software2019-10-22
ELEKTA LIMITED
Elekta Unity 2019-05-08
ELEKTA LIMITED
Elekta Unity 2019-05-08
Elekta Ltd
Clarity® 2019-04-04
ELEKTA LIMITED
Elekta Unity 2019-02-25
Elekta Ltd
Clarity® 2018-12-20
ELEKTA LIMITED [ELEKTA AB]
Unity2018-12-05
ELEKTA LIMITED [ELEKTA AB]
Unity MR-linac2018-12-05
ELEKTA LIMITED [ELEKTA AB]
Marlin 1.5T2018-12-05
ELEKTA LIMITED [ELEKTA AB]
Elekta Unity2018-12-05
Elekta Limited
Elekta Unity2018-12-04
ELEKTA LIMITED [ELEKTA AB]
Elekta Infinity;Elekta Medical Linear Accelerator;Elekta Synergy;Elekta Synergy Platform;Integrity;Integrity 4; Versa HD2018-10-22
Elekta Ltd
Clarity® 2018-07-06
Elekta Ltd
Clarity® 2018-07-06
Elekta Ltd
Clarity® 2018-07-06
Elekta Ltd
Clarity® 2018-07-06
Elekta Ltd
Clarity® 2018-07-06
Elekta Ltd
Clarity® 2018-07-06
Elekta Ltd
Clarity® 2018-07-06
Elekta Ltd
Clarity® 2018-07-06
Elekta Ltd
Clarity® 2018-07-06
Elekta Ltd
Clarity® 2018-07-06
Elekta Ltd
Clarity® 2018-07-06
Elekta Ltd
Clarity® 2018-07-06
Elekta Ltd
Clarity® 2018-07-06
Elekta Ltd
Clarity® 2018-07-06
Elekta Ltd
Clarity® 2018-07-06
Elekta Ltd
Clarity® 2018-07-06
Elekta Ltd
Clarity® 2018-07-06
Elekta Ltd
Clarity® 2018-07-06
Elekta Ltd
Clarity® 2018-07-06
ELEKTA LIMITED
Active Breathing Coordinator 2018-07-06
ELEKTA LIMITED
Active Breathing Coordinator 2018-07-06
ELEKTA LIMITED
Apex™ 2018-07-06
ELEKTA LIMITED
XVI 2018-07-06
ELEKTA LIMITED
XVI 2018-07-06
ELEKTA LIMITED
XVI 2018-07-06
ELEKTA LIMITED
XVI 2018-07-06
ELEKTA LIMITED
XVI 2018-07-06
ELEKTA LIMITED
XVI 2018-07-06
ELEKTA LIMITED
XVI 2018-07-06
ELEKTA LIMITED
XVI 2018-07-06
ELEKTA LIMITED
XVI 2018-07-06
ELEKTA LIMITED
XVI 2018-07-06
ELEKTA LIMITED
XVI 2018-07-06
ELEKTA LIMITED
XVI 2018-07-06
ELEKTA LIMITED
Precise Treatment Table™ 2018-07-06
ELEKTA LIMITED
Integrity™ 2018-07-06
ELEKTA LIMITED
Integrity™ 2018-07-06
ELEKTA LIMITED
iViewGT™ 2018-07-06
ELEKTA LIMITED
XVI 2018-07-06
ELEKTA LIMITED
MLCi2™ 2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
2018-07-06
ELEKTA LIMITED
Agility™ 2018-03-29
ELEKTA LIMITED [ELEKTA AB]
iViewDose2016-12-07
Elekta Limited
IViewDose R1.02015-12-11
ELEKTA LIMITED [ELEKTA AB]
Synergy XVI2015-12-03
ELEKTA LIMITED [ELEKTA AB]
Integrity 3.12015-12-03
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity?2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? TPUS Autoscan Probe Base Kit2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? TPUS Autoscan Probe (m4DC7-3/40)2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? System 310C002015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Software2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Remote Control2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? QA Phantom2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Optical Tracking System2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Linear Probe (L14-5W/60)2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Digitizer2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Curved Probe (C5-2/60)2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Calibration & QA Phantom2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? CPI, Railed2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? CPI, Rail-less2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Acquisition Station (310C00)2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity?2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? TPUS Autoscan Probe Base Kit2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? TPUS Autoscan Probe (m4DC7-3/40)2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? System 310C002015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Software2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Remote Control2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? QA Phantom2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Optical Tracking System2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Linear Probe (L14-5W/60)2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Digitizer2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Curved Probe (C5-2/60)2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Calibration & QA Phantom2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? CPI, Railed2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? CPI, Rail-less2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Acquisition Station (310C00)2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity?2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? TPUS Autoscan Probe Base Kit2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? TPUS Autoscan Probe (m4DC7-3/40)2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? System 310C002015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Software2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Remote Control2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? QA Phantom2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Optical Tracking System2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Linear Probe (L14-5W/60)2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Digitizer2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Curved Probe (C5-2/60)2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Calibration & QA Phantom2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? CPI, Railed2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? CPI, Rail-less2015-06-09
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Acquisition Station (310C00)2015-06-09
ELEKTA LTD.
CLARITY2014-10-08
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Acquisition Station 310C00 (REF 9100-00054)2013-12-12
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Acquisition Station 310C00 (REF 9100-00054)2013-12-12
ELEKTA LTD. [ELEKTA Instrument AB]
Clarity? Acquisition Station 310C00 (REF 9100-00054)2013-12-12
Elekta Limited
XVI R5.02013-09-25
ELEKTA LTD.
AGILITY2013-04-04
ELEKTA LTD.
CLARITY2012-12-05
ELEKTA LIMITED [ELEKTA AB]
Agility2012-10-24
ELEKTA LTD.
AGILITY2012-06-12
ELEKTA LIMITED [ELEKTA AB]
INTEGRITY2012-02-03
ELEKTA LIMITED [ELEKTA AB]
APEX2012-02-03
ELEKTA LIMITED [ELEKTA AB]
XVI 4.52012-02-03
ELEKTA LIMITED [ELEKTA AB]
MLCi22012-02-03
ELEKTA LTD.
CLARITY OBP SYSTEM2012-01-30
Elekta Limited
INTEGRITY(TM)2011-12-16
Elekta Limited
APEX2011-09-30
ELEKTA LTD.
INTEGRITY MODEL 10142842010-11-04
ELEKTA LTD.
XVI R4.52010-03-10
ELEKTA LIMITED [ELEKTA AB]
Stereotactic Cones2008-12-11
ELEKTA LIMITED [ELEKTA AB]
Stereotactic Collimator2008-12-11
ELEKTA LIMITED [ELEKTA AB]
Stereotactic Circular Collimator2008-12-11
ELEKTA LIMITED [ELEKTA AB]
Stereotactic Cones2008-12-11
ELEKTA LIMITED [ELEKTA AB]
Stereotactic Collimator2008-12-11
ELEKTA LIMITED [ELEKTA AB]
Stereotactic Circular Collimator2008-12-11
ELEKTA LTD.
MLCI22008-08-29
ELEKTA LTD.
DESKTOP PRO2008-06-11
ELEKTA LIMITED [ELEKTA AB]
Precise Treatment Table2008-04-10
ELEKTA LIMITED [ELEKTA AB]
Precise Table2008-04-10
ELEKTA LIMITED [ELEKTA AB]
Synergy Platform2008-04-10
ELEKTA LIMITED [ELEKTA AB]
Precise Treatment System2008-04-10
ELEKTA LIMITED [ELEKTA AB]
Precise Digital Accelerator2008-04-10
ELEKTA LIMITED [ELEKTA AB]
Elekta Synergy Platform2008-04-10
ELEKTA LIMITED [ELEKTA AB]
XVI2008-04-10
ELEKTA LIMITED [ELEKTA AB]
Versa HD2008-04-10
ELEKTA LIMITED [ELEKTA AB]
Synergy2008-04-10
ELEKTA LIMITED [ELEKTA AB]
Infinity2008-04-10
ELEKTA LIMITED [ELEKTA AB]
Elekta Synergy2008-04-10
ELEKTA LIMITED [ELEKTA AB]
Elekta Infinity2008-04-10
ELEKTA LIMITED [ELEKTA AB]
Elekta Axesse2008-04-10
ELEKTA LIMITED [ELEKTA AB]
Axesse2008-04-10
ELEKTA LIMITED [ELEKTA AB]
iView GT2008-04-10
ELEKTA LTD. [ELEKTA Instrument AB]
RESTITU2007-10-26
ELEKTA LTD. [ELEKTA Instrument AB]
CLARITY2007-10-26
ELEKTA LTD. [ELEKTA Instrument AB]
CLARITY U/S CONSOLE (REF 8010-00060)2007-10-26
ELEKTA LTD. [ELEKTA Instrument AB]
RESTITU2007-10-26
ELEKTA LTD. [ELEKTA Instrument AB]
CLARITY2007-10-26
ELEKTA LTD. [ELEKTA Instrument AB]
CLARITY U/S CONSOLE (REF 8010-00060)2007-10-26
ELEKTA LTD. [ELEKTA Instrument AB]
RESTITU2007-10-26
ELEKTA LTD. [ELEKTA Instrument AB]
CLARITY2007-10-26
ELEKTA LTD. [ELEKTA Instrument AB]
CLARITY U/S CONSOLE (REF 8010-00060)2007-10-26
ELEKTA LTD.
BEAM MODULATOR, MODEL 4513 332 80002005-01-31
ELEKTA LIMITED [ELEKTA AB]
iBEAM, various2004-10-14
ELEKTA LIMITED [ELEKTA AB]
Unity CT Overlay2004-10-14
ELEKTA LIMITED [ELEKTA AB]
Elekta Unity CT Overlay2004-10-14
ELEKTA LIMITED [ELEKTA AB]
Connexion, various2004-10-14

Similar & Related FDA Registered Companies

Related Finance Registrations
NCAGE CodeKCJF8ELEKTA LTD
CAGE CodeKCJF8ELEKTA LTD
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091028539Liverpool,United Kingdom -> New York/Newark Area, Newark, New JerseyEMPTY TRANSPORT CASE DIMS 116 X 96 X 159 131 X 107 X 160 130 X 104 X 160 FINAL CFS ATLANTA HS-CODE 44151010003 PKG
2020090239660Liverpool,United Kingdom -> New York/Newark Area, Newark, New JerseyEMPTY TRANSPORT CASE DIMS 116 X 96 X 159 131 X 107 X 160 130 X 104 X 160 FINAL CFS ATLANTA HS-CODE 44151010003 PKG
2020082850333Liverpool,United Kingdom -> New York/Newark Area, Newark, New JerseyEMPTY TRANSPORT CASE DIMS 116 X 96 X 159 131 X 107 X 160 130 X 104 X 160 FINAL CFS ATLANTA HS-CODE 44151010003 PKG
2020082654073Liverpool,United Kingdom -> New York/Newark Area, Newark, New JerseyEMPTY TRANSPORT CASE DIMS 116 X 96 X 159 131 X 107 X 160 130 X 104 X 160 FINAL CFS ATLANTA HS-CODE 44151010003 PKG
2020082573857Liverpool,United Kingdom -> New York/Newark Area, Newark, New JerseyEMPTY TRANSPORT CASE DIMS 116 X 96 X 159 131 X 107 X 160 130 X 104 X 160 FINAL CFS ATLANTA HS-CODE 44151010003 PKG
2020082063562London,United Kingdom -> New York/Newark Area, Newark, New Jersey40 BOXES CONSISTING OF 23 WOODEN CASES 14 PLYWOOD CASES 3 CARDBOARD CARTONS CONTAINING MEDICAL EQUIPMENT HS-CODE 9022140044 BOX
2020082063562London,United Kingdom -> New York/Newark Area, Newark, New Jersey4 BOXES CONSISTING OF 3 WOODEN CASES 1 PLYWOOD CASES 0 CARDBOARD CARTONS CONTAINING MEDICAL EQUIPMENT HS-CODE 9022140044 BOX
202008123685London,United Kingdom -> Savannah, GeorgiaCONTAINING 26 WOODEN CASES, 16 PLYWOOD CASES 4 CARDBOARD CARTONS CONTAINING MEDICAL EQUIPMENT HS-CODE 9022140046 PKG
2020081110470London,United Kingdom -> Savannah, GeorgiaCONTAINING 24 WOODEN CASES, 14 PLYWOOD CASES 3 CARDBOARD CARTONS CONTAINING MEDICAL EQUIPMENT HS-CODE 902214000045 PKG
2020081110470London,United Kingdom -> Savannah, GeorgiaCONTAINING 3 WOODEN CASES, 1 PLYWOOD CASES HS-CODE 902214000045 PKG

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