Elekta Solutions Ab

FDA Filings

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

FDA Registration(s)
Registration Number3015232217
FEI Number3015232217
NameELEKTA SOLUTIONS AB
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 AddressKUNGSTENSGATAN 18 Box 7593
STOCKHOLM Stockholms lan [SE-01], SE10393 SE
Establishment TypeExport Device to the United States But Perform No Other Operation on Device



FDA Filings

Device
Company
DeviceDate
Elekta Solutions AB
MOSAIQ Oncology Information System2020-12-18
ELEKTA SOLUTIONS AB [ELEKTA AB]
Monaco2018-12-05
ELEKTA SOLUTIONS AB [ELEKTA AB]
Monaco RTP System2018-12-05
ELEKTA SOLUTIONS AB [ELEKTA AB]
MOSAIQ2018-12-05
ELEKTA SOLUTIONS AB [ELEKTA AB]
MOSAIQ Oncology Information System2018-12-05
ELEKTA SOLUTIONS AB [ELEKTA AB]
Unity2018-12-05
ELEKTA SOLUTIONS AB [ELEKTA AB]
Unity MR-linac2018-12-05
ELEKTA SOLUTIONS AB [ELEKTA AB]
Marlin 1.5T2018-12-05
ELEKTA SOLUTIONS AB [ELEKTA AB]
Elekta Unity2018-12-05
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Gamma Knife2018-10-16
ELEKTA SOLUTIONS AB [ELEKTA AB]
BodyFIX System2018-10-15
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Gamma Plan 11.12018-02-12
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Gamma Plan 11.12018-02-12
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Vantage Stereotactic System2017-12-06
ELEKTA SOLUTIONS AB [ELEKTA AB]
Advanced Gynecological Applicator2017-01-30
ELEKTA SOLUTIONS AB [ELEKTA AB]
iViewDose2016-12-07
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Gamma Knife? Icon?2016-04-29
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Gamma Knife Perfexion2016-04-01
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Stereotactic System?2016-03-03
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell GammaPlan?2016-02-26
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Gamma Knife? Icon?2016-02-26
ELEKTA SOLUTIONS AB [ELEKTA AB]
Synergy XVI2015-12-03
ELEKTA SOLUTIONS AB [ELEKTA AB]
Integrity 3.12015-12-03
ELEKTA SOLUTIONS AB [ELEKTA AB]
Monaco RTP System2015-07-23
ELEKTA SOLUTIONS AB [ELEKTA AB]
XiO RTP System2015-04-27
ELEKTA SOLUTIONS AB [ELEKTA AB]
Focus RTP System2015-04-27
ELEKTA SOLUTIONS AB [ELEKTA AB]
MOSAIQ Oncology Information System2015-04-27
ELEKTA SOLUTIONS AB [ELEKTA AB]
MOSAIQ Oncology Information System2015-04-27
ELEKTA SOLUTIONS AB [ELEKTA AB]
Monaco RTP System2015-04-27
ELEKTA SOLUTIONS AB [ELEKTA AB]
MOSAIQ Oncology Information System2015-04-27
ELEKTA SOLUTIONS AB [ELEKTA AB]
Monaco RTP System2015-04-27
ELEKTA SOLUTIONS AB [ELEKTA AB]
XiO RTP System2015-04-27
ELEKTA SOLUTIONS AB [ELEKTA AB]
XiO RTP System2015-04-27
ELEKTA SOLUTIONS AB [ELEKTA AB]
Monaco RTP System2015-04-27
ELEKTA SOLUTIONS AB [ELEKTA AB]
XiO RTP System2015-04-27
ELEKTA SOLUTIONS AB [ELEKTA AB]
XiO RTP System2015-04-27
ELEKTA SOLUTIONS AB [ELEKTA AB]
Ergo++2015-04-27
ELEKTA SOLUTIONS AB [ELEKTA AB]
XiO RTP System2015-04-27
ELEKTA SOLUTIONS AB [ELEKTA AB]
Focus RTP System2015-04-27
ELEKTA SOLUTIONS AB [ELEKTA AB]
Focal Workstation2015-04-27
ELEKTA SOLUTIONS AB [ELEKTA AB]
XiO RTP System2015-04-27
ELEKTA SOLUTIONS AB [ELEKTA AB]
Focus RTP System2015-04-27
ELEKTA SOLUTIONS AB [ELEKTA AB]
STEALTHSTATION PASSIVE INSTRUMENT OPTION2012-12-04
ELEKTA SOLUTIONS AB [ELEKTA AB]
INST 960-539 GUIDE, BIOPSY2012-12-04
ELEKTA SOLUTIONS AB [ELEKTA AB]
STEALTHSTATION SYSTEM UPDATE2012-12-04
ELEKTA SOLUTIONS AB [ELEKTA AB]
ARM 9734252 VERTEK II2012-12-04
ELEKTA SOLUTIONS AB [ELEKTA AB]
Agility2012-10-24
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Gamma Knife Perfexion2012-10-19
ELEKTA SOLUTIONS AB [ELEKTA AB]
Fraxion2012-05-18
ELEKTA SOLUTIONS AB [ELEKTA AB]
MOSAIQ Oncology Information System2012-03-05
ELEKTA SOLUTIONS AB [ELEKTA AB]
INTEGRITY2012-02-03
ELEKTA SOLUTIONS AB [ELEKTA AB]
APEX2012-02-03
ELEKTA SOLUTIONS AB [ELEKTA AB]
XVI 4.52012-02-03
ELEKTA SOLUTIONS AB [ELEKTA AB]
MLCi22012-02-03
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell GammaPlan2011-12-14
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell GammaKnife Perfexion2009-12-01
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell GammaPlan2009-12-01
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Stereotactic System2009-12-01
ELEKTA SOLUTIONS AB [ELEKTA AB]
ERGO++2009-05-12
ELEKTA SOLUTIONS AB [ELEKTA AB]
MOSAIQ Oncology PACS2009-01-07
ELEKTA SOLUTIONS AB [ELEKTA AB]
MOSAIQ Data Director2009-01-07
ELEKTA SOLUTIONS AB [ELEKTA AB]
MOSAIQ Instrument Manager2009-01-07
ELEKTA SOLUTIONS AB [ELEKTA AB]
MOSAIQ ESI:Lab Instrument Interface2009-01-07
ELEKTA SOLUTIONS AB [ELEKTA AB]
Atlas-based Autosegmantation2008-12-12
ELEKTA SOLUTIONS AB [ELEKTA AB]
ABAS2008-12-12
ELEKTA SOLUTIONS AB [ELEKTA AB]
Atlas-based Autosegmantation2008-12-12
ELEKTA SOLUTIONS AB [ELEKTA AB]
ABAS2008-12-12
ELEKTA SOLUTIONS AB [ELEKTA AB]
Stereotactic Cones2008-12-11
ELEKTA SOLUTIONS AB [ELEKTA AB]
Stereotactic Collimator2008-12-11
ELEKTA SOLUTIONS AB [ELEKTA AB]
Stereotactic Circular Collimator2008-12-11
ELEKTA SOLUTIONS AB [ELEKTA AB]
Stereotactic Cones2008-12-11
ELEKTA SOLUTIONS AB [ELEKTA AB]
Stereotactic Collimator2008-12-11
ELEKTA SOLUTIONS AB [ELEKTA AB]
Stereotactic Circular Collimator2008-12-11
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Gamma Knife2008-11-19
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell SurgiPlan2008-11-19
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Gamma Knife Perfexion2008-11-19
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Gamma Knife Perfexion2008-11-19
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Gamma Plan2008-11-19
ELEKTA SOLUTIONS AB [ELEKTA AB]
Elekta Esarte Frame System2008-11-19
ELEKTA SOLUTIONS AB [ELEKTA AB]
Elekta Esarte Frame System2008-11-19
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Gamma Plan2008-11-19
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Gamma Plan2008-11-19
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Gamma Plan2008-11-19
ELEKTA SOLUTIONS AB [ELEKTA AB]
Elekta Microdrive2008-11-19
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell SurgiPlan2008-11-19
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Stereotactic System2008-11-19
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell Stereotactic System2008-11-19
ELEKTA SOLUTIONS AB [ELEKTA AB]
Leksell SurgiPlan2008-11-19
ELEKTA SOLUTIONS AB [ELEKTA AB]
FOCAL2008-08-01
ELEKTA SOLUTIONS AB [ELEKTA AB]
FOCUS/XiO2008-08-01
ELEKTA SOLUTIONS AB [ELEKTA AB]
Monaco2008-08-01
ELEKTA SOLUTIONS AB [ELEKTA AB]
Precise Treatment Table2008-04-10
ELEKTA SOLUTIONS AB [ELEKTA AB]
Precise Table2008-04-10
ELEKTA SOLUTIONS AB [ELEKTA AB]
Synergy Platform2008-04-10
ELEKTA SOLUTIONS AB [ELEKTA AB]
Precise Treatment System2008-04-10
ELEKTA SOLUTIONS AB [ELEKTA AB]
Precise Digital Accelerator2008-04-10
ELEKTA SOLUTIONS AB [ELEKTA AB]
Elekta Synergy Platform2008-04-10
ELEKTA SOLUTIONS AB [ELEKTA AB]
XVI2008-04-10
ELEKTA SOLUTIONS AB [ELEKTA AB]
Versa HD2008-04-10
ELEKTA SOLUTIONS AB [ELEKTA AB]
Synergy2008-04-10
ELEKTA SOLUTIONS AB [ELEKTA AB]
Infinity2008-04-10
ELEKTA SOLUTIONS AB [ELEKTA AB]
Elekta Synergy2008-04-10
ELEKTA SOLUTIONS AB [ELEKTA AB]
Elekta Infinity2008-04-10
ELEKTA SOLUTIONS AB [ELEKTA AB]
Elekta Axesse2008-04-10
ELEKTA SOLUTIONS AB [ELEKTA AB]
Axesse2008-04-10
ELEKTA SOLUTIONS AB [ELEKTA AB]
iView GT2008-04-10
ELEKTA SOLUTIONS AB [ELEKTA AB]
SEQUENCER2007-12-17
ELEKTA SOLUTIONS AB [ELEKTA AB]
HEXAPOD COUCH TOP2006-10-25
ELEKTA SOLUTIONS AB [ELEKTA AB]
ATLAS INTERVENTION2005-10-17
ELEKTA SOLUTIONS AB [ELEKTA AB]
iBEAM, various2004-10-14
ELEKTA SOLUTIONS AB [ELEKTA AB]
Unity CT Overlay2004-10-14
ELEKTA SOLUTIONS AB [ELEKTA AB]
Elekta Unity CT Overlay2004-10-14
ELEKTA SOLUTIONS AB [ELEKTA AB]
Connexion, various2004-10-14
ELEKTA SOLUTIONS AB [ELEKTA AB]
TARGET POSITIONER UNIT2001-05-15
ELEKTA SOLUTIONS AB [ELEKTA AB]
HEADFIX AND LOCALIZER2001-05-15

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
20200626300Anvers,Belgium -> Savannah, GeorgiaOF WHICH 25 WOODEN, 15 PLYWOOD CASES AND 4 CARD- BOARD CARTONS MEDICAL EQUIPMENT ELEKTA VERSA LINEAR ACCELERATOR HS-CODE(S) 90221400 BAL ECB ANR222753144 PKG
2020041157507London,United Kingdom -> New York, New York5 WOODEN CASES 15 PLYWOOD CASES 2 CARDBOARD CARTONS CONTAINING MEDICAL EQUIPMENT LINEAR ACCELERATOR MODEL ELEKTA VERSA ONE SET CONTAINERS SAID TO CONTAIN . . .42 PCS
2020021219930Anvers,Belgium -> Savannah, GeorgiaOF WHICH 25 WOODEN, 15 PLYWOOD CASES AND 4 CARD- BOARD CARTONS MEDICAL EQUIPMENT ELEKTA VERSA LINEAR ACCELERATOR HS-CODE(S) 90221400 BAL ECB ANR222753144 PKG
2020011718996Anvers,Belgium -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT ELEKTA VERSA LINEAR ACCELERATOR HS-CODE(S) 90221400 BAL ECB ANR222506645 PKG

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