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.
Registration Number | 3008317722 |
FEI Number | 3008317722 |
Name | ELEKTA LTD. |
Owner & Operator | ELEKTA AB |
Contact Address | KUNGSTENSGATAN 18 Box 7593 STOCKHOLM SE-AB Stockholms lan [SE-01] SE10393 SE |
US Agent |
|
Registration Status | 1 |
Initial Importer | N |
Registration Expiration | 2020-04-25 |
Registration Address | 555 Richmond Street West, Suite 1001 Toronto Ontario, M5V3B1 CA |
Establishment Type | Develop Specifications But Do Not Manufacture At This Facility |
Registration Number | 9617016 |
FEI Number | 3002806900 |
Name | ELEKTA LIMITED |
Owner & Operator | ELEKTA AB |
Contact Address | KUNGSTENSGATAN 18 Box 7593 STOCKHOLM SE-AB Stockholms lan [SE-01] SE10393 SE |
US Agent |
|
Registration Status | 1 |
Initial Importer | N |
Registration Expiration | 2020-04-25 |
Registration Address | FLEMING WAY CRAWLEY West Sussex, RH10 9RR GB |
Establishment Type |
|
Registration Number | 3004747535 |
FEI Number | 3004747535 |
Name | ELEKTA LTD. |
Owner & Operator | ELEKTA Instrument AB |
Contact Address | Kungstensgatan 18 Stockholm SE-AB Stockholms lan [SE-01] 11357 SE |
US Agent |
|
Registration Status | 1 |
Initial Importer | N |
Registration Expiration | 2020-04-25 |
Registration Address | 2050 BLEURY, SUITE 200 MONTREAL Quebec, H3A 2J5 CA |
Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
---|---|---|
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 HD | 2021-06-11 |
Elekta Ltd | Clarity® | 2020-06-29 |
ELEKTA LIMITED [ELEKTA AB] | Elekta Unity | 2020-02-26 |
ELEKTA LIMITED [ELEKTA AB] | Elekta Synergy Platform, Synergy, Infinity, Versa HD | 2020-02-26 |
ELEKTA LIMITED | Integrity™ | 2020-01-20 |
Elekta Limited | Elekta Unity | 2019-12-05 |
Elekta Limited | Synergy Platform, Synergy, Infinity, VersaHD | 2019-11-22 |
ELEKTA LTD. [ELEKTA AB] | AQUA Software | 2019-10-22 |
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] | Unity | 2018-12-05 |
ELEKTA LIMITED [ELEKTA AB] | Unity MR-linac | 2018-12-05 |
ELEKTA LIMITED [ELEKTA AB] | Marlin 1.5T | 2018-12-05 |
ELEKTA LIMITED [ELEKTA AB] | Elekta Unity | 2018-12-05 |
Elekta Limited | Elekta Unity | 2018-12-04 |
ELEKTA LIMITED [ELEKTA AB] | Elekta Infinity;Elekta Medical Linear Accelerator;Elekta Synergy;Elekta Synergy Platform;Integrity;Integrity 4; Versa HD | 2018-10-22 |
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] | iViewDose | 2016-12-07 |
Elekta Limited | IViewDose R1.0 | 2015-12-11 |
ELEKTA LIMITED [ELEKTA AB] | Synergy XVI | 2015-12-03 |
ELEKTA LIMITED [ELEKTA AB] | Integrity 3.1 | 2015-12-03 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? TPUS Autoscan Probe Base Kit | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? TPUS Autoscan Probe (m4DC7-3/40) | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? System 310C00 | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Software | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Remote Control | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? QA Phantom | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Optical Tracking System | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Linear Probe (L14-5W/60) | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Digitizer | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Curved Probe (C5-2/60) | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Calibration & QA Phantom | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? CPI, Railed | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? CPI, Rail-less | 2015-06-09 |
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 Kit | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? TPUS Autoscan Probe (m4DC7-3/40) | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? System 310C00 | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Software | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Remote Control | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? QA Phantom | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Optical Tracking System | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Linear Probe (L14-5W/60) | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Digitizer | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Curved Probe (C5-2/60) | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Calibration & QA Phantom | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? CPI, Railed | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? CPI, Rail-less | 2015-06-09 |
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 Kit | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? TPUS Autoscan Probe (m4DC7-3/40) | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? System 310C00 | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Software | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Remote Control | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? QA Phantom | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Optical Tracking System | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Linear Probe (L14-5W/60) | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Digitizer | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Curved Probe (C5-2/60) | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Calibration & QA Phantom | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? CPI, Railed | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? CPI, Rail-less | 2015-06-09 |
ELEKTA LTD. [ELEKTA Instrument AB] | Clarity? Acquisition Station (310C00) | 2015-06-09 |
ELEKTA LTD. | CLARITY | 2014-10-08 |
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 R5.0 | 2013-09-25 |
ELEKTA LTD. | AGILITY | 2013-04-04 |
ELEKTA LTD. | CLARITY | 2012-12-05 |
ELEKTA LIMITED [ELEKTA AB] | Agility | 2012-10-24 |
ELEKTA LTD. | AGILITY | 2012-06-12 |
ELEKTA LIMITED [ELEKTA AB] | INTEGRITY | 2012-02-03 |
ELEKTA LIMITED [ELEKTA AB] | APEX | 2012-02-03 |
ELEKTA LIMITED [ELEKTA AB] | XVI 4.5 | 2012-02-03 |
ELEKTA LIMITED [ELEKTA AB] | MLCi2 | 2012-02-03 |
ELEKTA LTD. | CLARITY OBP SYSTEM | 2012-01-30 |
Elekta Limited | INTEGRITY(TM) | 2011-12-16 |
Elekta Limited | APEX | 2011-09-30 |
ELEKTA LTD. | INTEGRITY MODEL 1014284 | 2010-11-04 |
ELEKTA LTD. | XVI R4.5 | 2010-03-10 |
ELEKTA LIMITED [ELEKTA AB] | Stereotactic Cones | 2008-12-11 |
ELEKTA LIMITED [ELEKTA AB] | Stereotactic Collimator | 2008-12-11 |
ELEKTA LIMITED [ELEKTA AB] | Stereotactic Circular Collimator | 2008-12-11 |
ELEKTA LIMITED [ELEKTA AB] | Stereotactic Cones | 2008-12-11 |
ELEKTA LIMITED [ELEKTA AB] | Stereotactic Collimator | 2008-12-11 |
ELEKTA LIMITED [ELEKTA AB] | Stereotactic Circular Collimator | 2008-12-11 |
ELEKTA LTD. | MLCI2 | 2008-08-29 |
ELEKTA LTD. | DESKTOP PRO | 2008-06-11 |
ELEKTA LIMITED [ELEKTA AB] | Precise Treatment Table | 2008-04-10 |
ELEKTA LIMITED [ELEKTA AB] | Precise Table | 2008-04-10 |
ELEKTA LIMITED [ELEKTA AB] | Synergy Platform | 2008-04-10 |
ELEKTA LIMITED [ELEKTA AB] | Precise Treatment System | 2008-04-10 |
ELEKTA LIMITED [ELEKTA AB] | Precise Digital Accelerator | 2008-04-10 |
ELEKTA LIMITED [ELEKTA AB] | Elekta Synergy Platform | 2008-04-10 |
ELEKTA LIMITED [ELEKTA AB] | XVI | 2008-04-10 |
ELEKTA LIMITED [ELEKTA AB] | Versa HD | 2008-04-10 |
ELEKTA LIMITED [ELEKTA AB] | Synergy | 2008-04-10 |
ELEKTA LIMITED [ELEKTA AB] | Infinity | 2008-04-10 |
ELEKTA LIMITED [ELEKTA AB] | Elekta Synergy | 2008-04-10 |
ELEKTA LIMITED [ELEKTA AB] | Elekta Infinity | 2008-04-10 |
ELEKTA LIMITED [ELEKTA AB] | Elekta Axesse | 2008-04-10 |
ELEKTA LIMITED [ELEKTA AB] | Axesse | 2008-04-10 |
ELEKTA LIMITED [ELEKTA AB] | iView GT | 2008-04-10 |
ELEKTA LTD. [ELEKTA Instrument AB] | RESTITU | 2007-10-26 |
ELEKTA LTD. [ELEKTA Instrument AB] | CLARITY | 2007-10-26 |
ELEKTA LTD. [ELEKTA Instrument AB] | CLARITY U/S CONSOLE (REF 8010-00060) | 2007-10-26 |
ELEKTA LTD. [ELEKTA Instrument AB] | RESTITU | 2007-10-26 |
ELEKTA LTD. [ELEKTA Instrument AB] | CLARITY | 2007-10-26 |
ELEKTA LTD. [ELEKTA Instrument AB] | CLARITY U/S CONSOLE (REF 8010-00060) | 2007-10-26 |
ELEKTA LTD. [ELEKTA Instrument AB] | RESTITU | 2007-10-26 |
ELEKTA LTD. [ELEKTA Instrument AB] | CLARITY | 2007-10-26 |
ELEKTA LTD. [ELEKTA Instrument AB] | CLARITY U/S CONSOLE (REF 8010-00060) | 2007-10-26 |
ELEKTA LTD. | BEAM MODULATOR, MODEL 4513 332 8000 | 2005-01-31 |
ELEKTA LIMITED [ELEKTA AB] | iBEAM, various | 2004-10-14 |
ELEKTA LIMITED [ELEKTA AB] | Unity CT Overlay | 2004-10-14 |
ELEKTA LIMITED [ELEKTA AB] | Elekta Unity CT Overlay | 2004-10-14 |
ELEKTA LIMITED [ELEKTA AB] | Connexion, various | 2004-10-14 |
NCAGE Code | KCJF8 | ELEKTA LTD |
CAGE Code | KCJF8 | ELEKTA LTD |
Import ID | Shipment | Cargo Description | Quantity |
---|---|---|---|
2020091028539 | Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey | EMPTY TRANSPORT CASE DIMS 116 X 96 X 159 131 X 107 X 160 130 X 104 X 160 FINAL CFS ATLANTA HS-CODE 4415101000 | 3 PKG |
2020090239660 | Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey | EMPTY TRANSPORT CASE DIMS 116 X 96 X 159 131 X 107 X 160 130 X 104 X 160 FINAL CFS ATLANTA HS-CODE 4415101000 | 3 PKG |
2020082850333 | Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey | EMPTY TRANSPORT CASE DIMS 116 X 96 X 159 131 X 107 X 160 130 X 104 X 160 FINAL CFS ATLANTA HS-CODE 4415101000 | 3 PKG |
2020082654073 | Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey | EMPTY TRANSPORT CASE DIMS 116 X 96 X 159 131 X 107 X 160 130 X 104 X 160 FINAL CFS ATLANTA HS-CODE 4415101000 | 3 PKG |
2020082573857 | Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey | EMPTY TRANSPORT CASE DIMS 116 X 96 X 159 131 X 107 X 160 130 X 104 X 160 FINAL CFS ATLANTA HS-CODE 4415101000 | 3 PKG |
2020082063562 | London,United Kingdom -> New York/Newark Area, Newark, New Jersey | 40 BOXES CONSISTING OF 23 WOODEN CASES 14 PLYWOOD CASES 3 CARDBOARD CARTONS CONTAINING MEDICAL EQUIPMENT HS-CODE 90221400 | 44 BOX |
2020082063562 | London,United Kingdom -> New York/Newark Area, Newark, New Jersey | 4 BOXES CONSISTING OF 3 WOODEN CASES 1 PLYWOOD CASES 0 CARDBOARD CARTONS CONTAINING MEDICAL EQUIPMENT HS-CODE 90221400 | 44 BOX |
202008123685 | London,United Kingdom -> Savannah, Georgia | CONTAINING 26 WOODEN CASES, 16 PLYWOOD CASES 4 CARDBOARD CARTONS CONTAINING MEDICAL EQUIPMENT HS-CODE 90221400 | 46 PKG |
2020081110470 | London,United Kingdom -> Savannah, Georgia | CONTAINING 24 WOODEN CASES, 14 PLYWOOD CASES 3 CARDBOARD CARTONS CONTAINING MEDICAL EQUIPMENT HS-CODE 9022140000 | 45 PKG |
2020081110470 | London,United Kingdom -> Savannah, Georgia | CONTAINING 3 WOODEN CASES, 1 PLYWOOD CASES HS-CODE 9022140000 | 45 PKG |