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.
Registration Number | 3015232217 |
FEI Number | 3015232217 |
Name | ELEKTA SOLUTIONS AB |
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 | KUNGSTENSGATAN 18 Box 7593 STOCKHOLM Stockholms lan [SE-01], SE10393 SE |
Establishment Type | Export Device to the United States But Perform No Other Operation on Device |
Device Company | Device | Date |
---|---|---|
Elekta Solutions AB | Leksell Vantage Stereotactic System | 2024-12-09 |
Elekta Solutions AB | Leksell Vantage Stereotactic System 1040051 | 2024-12-09 |
Elekta Solutions AB | Leksell Vantage Stereotactic System 1060488 | 2024-12-09 |
Elekta Solutions AB | Leksell Vantage Stereotactic System | 2024-09-09 |
Elekta Solutions AB | Leksell Vantage Stereotactic System | 2024-08-22 |
Elekta Solutions AB | Leksell Vantage Stereotactic System 1040035 | 2024-08-14 |
Elekta Solutions AB | Leksell Vantage Stereotactic System 1040034 | 2024-08-13 |
Elekta Solutions AB | Leksell Vantage Stereotactic System 1040033 | 2024-08-13 |
Elekta Solutions AB | Leksell Vantage Stereotactic System 1040032 | 2024-07-12 |
Elekta Solutions AB | Leksell Vantage Stereotactic System 1040031 | 2024-07-12 |
Elekta Solutions AB | Leksell Vantage Stereotactic System 1040100 | 2024-06-28 |
Elekta Solutions AB | Leksell Vantage Stereotactic System 1040096 | 2024-06-28 |
Elekta Solutions AB | Leksell Vantage Stereotactic System 1040093 | 2024-06-28 |
Elekta Solutions AB | Leksell Vantage Stereotactic System 1040090 | 2024-06-28 |
Elekta Solutions AB | Leksell Vantage Stereotactic System 1040014 | 2024-06-26 |
Elekta Solutions AB | Leksell Vantage Stereotactic System 1040027 | 2024-06-26 |
Elekta Solutions AB | Leksell Vantage Stereotactic System 1040110 | 2024-06-25 |
Elekta Solutions AB | Leksell Vantage Stereotactic System 1040114 | 2024-06-25 |
Elekta Solutions AB | Leksell Vantage Stereotactic System 1040045 | 2024-06-25 |
Elekta Solutions AB | Leksell Vantage Stereotactic System 1040036 | 2024-06-19 |
Elekta Solutions AB | Leksell Vantage Stereotactic System 1040036 | 2024-06-07 |
Elekta Solutions AB | ProKnow DS | 2024-03-29 |
Elekta Solutions AB | Leksell GammaPlan | 2024-02-22 |
Elekta Solutions AB | Clarity® | 2023-06-30 |
Elekta Solutions AB | MOSAIQ | 2023-04-12 |
Elekta Solutions AB | Monaco | 2023-04-12 |
Elekta Solutions AB | Leksell Gamma Knife Esprit | 2023-04-04 |
Elekta Solutions AB | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New Model Variant) | 2022-10-26 |
Elekta Solutions AB | Monaco | 2022-07-19 |
Elekta Solutions AB | AATMA | 2022-03-17 |
Elekta Solutions AB | Elekta Unity | 2021-10-01 |
Elekta Solutions AB | MOSAIQ | 2021-08-24 |
Elekta Solutions AB | Elekta Medical Linear Accelerator | 2021-08-09 |
Elekta Solutions AB | Elekta Medical Linear Accelerator | 2021-08-09 |
Elekta Solutions AB | Elekta Medical Linear Accelerator | 2021-08-09 |
Elekta Solutions AB | Elekta Medical Linear Accelerator | 2021-08-09 |
Elekta Solutions AB | Elekta Medical Linear Accelerator | 2021-08-09 |
Elekta Solutions AB | Elekta Medical Linear Accelerator | 2021-08-09 |
Elekta Solutions AB | Elekta Medical Linear Accelerator | 2021-08-09 |
Elekta Solutions AB | Elekta Medical Linear Accelerator | 2021-08-09 |
Elekta Solutions AB | MOSAIQ Oncology Information System | 2020-12-18 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Monaco | 2018-12-05 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Monaco RTP System | 2018-12-05 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | MOSAIQ | 2018-12-05 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | MOSAIQ Oncology Information System | 2018-12-05 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Unity | 2018-12-05 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Unity MR-linac | 2018-12-05 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Marlin 1.5T | 2018-12-05 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Elekta Unity | 2018-12-05 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell Gamma Knife | 2018-10-16 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | BodyFIX System | 2018-10-15 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell Gamma Plan 11.1 | 2018-02-12 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell Gamma Plan 11.1 | 2018-02-12 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell Vantage Stereotactic System | 2017-12-06 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Advanced Gynecological Applicator | 2017-01-30 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | iViewDose | 2016-12-07 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell Gamma Knife? Icon? | 2016-04-29 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell Gamma Knife Perfexion | 2016-04-01 |
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 XVI | 2015-12-03 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Integrity 3.1 | 2015-12-03 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Monaco RTP System | 2015-07-23 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | XiO RTP System | 2015-04-27 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Focus RTP System | 2015-04-27 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | MOSAIQ Oncology Information System | 2015-04-27 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | MOSAIQ Oncology Information System | 2015-04-27 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Monaco RTP System | 2015-04-27 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | MOSAIQ Oncology Information System | 2015-04-27 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Monaco RTP System | 2015-04-27 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | XiO RTP System | 2015-04-27 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | XiO RTP System | 2015-04-27 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Monaco RTP System | 2015-04-27 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | XiO RTP System | 2015-04-27 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | XiO RTP System | 2015-04-27 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Ergo++ | 2015-04-27 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | XiO RTP System | 2015-04-27 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Focus RTP System | 2015-04-27 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Focal Workstation | 2015-04-27 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | XiO RTP System | 2015-04-27 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Focus RTP System | 2015-04-27 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | STEALTHSTATION PASSIVE INSTRUMENT OPTION | 2012-12-04 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | INST 960-539 GUIDE, BIOPSY | 2012-12-04 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | STEALTHSTATION SYSTEM UPDATE | 2012-12-04 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | ARM 9734252 VERTEK II | 2012-12-04 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Agility | 2012-10-24 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell Gamma Knife Perfexion | 2012-10-19 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Fraxion | 2012-05-18 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | MOSAIQ Oncology Information System | 2012-03-05 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | INTEGRITY | 2012-02-03 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | APEX | 2012-02-03 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | XVI 4.5 | 2012-02-03 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | MLCi2 | 2012-02-03 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell GammaPlan | 2011-12-14 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell GammaKnife Perfexion | 2009-12-01 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell GammaPlan | 2009-12-01 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell Stereotactic System | 2009-12-01 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | ERGO++ | 2009-05-12 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | MOSAIQ Oncology PACS | 2009-01-07 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | MOSAIQ Data Director | 2009-01-07 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | MOSAIQ Instrument Manager | 2009-01-07 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | MOSAIQ ESI:Lab Instrument Interface | 2009-01-07 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Atlas-based Autosegmantation | 2008-12-12 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | ABAS | 2008-12-12 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Atlas-based Autosegmantation | 2008-12-12 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | ABAS | 2008-12-12 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Stereotactic Cones | 2008-12-11 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Stereotactic Collimator | 2008-12-11 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Stereotactic Circular Collimator | 2008-12-11 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Stereotactic Cones | 2008-12-11 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Stereotactic Collimator | 2008-12-11 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Stereotactic Circular Collimator | 2008-12-11 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell Gamma Knife | 2008-11-19 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell SurgiPlan | 2008-11-19 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell Gamma Knife Perfexion | 2008-11-19 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell Gamma Knife Perfexion | 2008-11-19 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell Gamma Plan | 2008-11-19 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Elekta Esarte Frame System | 2008-11-19 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Elekta Esarte Frame System | 2008-11-19 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell Gamma Plan | 2008-11-19 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell Gamma Plan | 2008-11-19 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell Gamma Plan | 2008-11-19 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Elekta Microdrive | 2008-11-19 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell SurgiPlan | 2008-11-19 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell Stereotactic System | 2008-11-19 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell Stereotactic System | 2008-11-19 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Leksell SurgiPlan | 2008-11-19 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | FOCAL | 2008-08-01 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | FOCUS/XiO | 2008-08-01 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Monaco | 2008-08-01 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Precise Treatment Table | 2008-04-10 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Precise Table | 2008-04-10 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Synergy Platform | 2008-04-10 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Precise Treatment System | 2008-04-10 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Precise Digital Accelerator | 2008-04-10 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Elekta Synergy Platform | 2008-04-10 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | XVI | 2008-04-10 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Versa HD | 2008-04-10 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Synergy | 2008-04-10 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Infinity | 2008-04-10 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Elekta Synergy | 2008-04-10 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Elekta Infinity | 2008-04-10 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Elekta Axesse | 2008-04-10 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Axesse | 2008-04-10 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | iView GT | 2008-04-10 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | SEQUENCER | 2007-12-17 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | HEXAPOD COUCH TOP | 2006-10-25 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | ATLAS INTERVENTION | 2005-10-17 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | iBEAM, various | 2004-10-14 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Unity CT Overlay | 2004-10-14 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Elekta Unity CT Overlay | 2004-10-14 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | Connexion, various | 2004-10-14 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | TARGET POSITIONER UNIT | 2001-05-15 |
ELEKTA SOLUTIONS AB [ELEKTA AB] | HEADFIX AND LOCALIZER | 2001-05-15 |
Import ID | Shipment | Cargo Description | Quantity |
---|---|---|---|
20200626300 | Anvers,Belgium -> Savannah, Georgia | OF WHICH 25 WOODEN, 15 PLYWOOD CASES AND 4 CARD- BOARD CARTONS MEDICAL EQUIPMENT ELEKTA VERSA LINEAR ACCELERATOR HS-CODE(S) 90221400 BAL ECB ANR2227531 | 44 PKG |
2020041157507 | London,United Kingdom -> New York, New York | 5 WOODEN CASES 15 PLYWOOD CASES 2 CARDBOARD CARTONS CONTAINING MEDICAL EQUIPMENT LINEAR ACCELERATOR MODEL ELEKTA VERSA ONE SET CONTAINERS SAID TO CONTAIN . . . | 42 PCS |
2020021219930 | Anvers,Belgium -> Savannah, Georgia | OF WHICH 25 WOODEN, 15 PLYWOOD CASES AND 4 CARD- BOARD CARTONS MEDICAL EQUIPMENT ELEKTA VERSA LINEAR ACCELERATOR HS-CODE(S) 90221400 BAL ECB ANR2227531 | 44 PKG |
2020011718996 | Anvers,Belgium -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENT ELEKTA VERSA LINEAR ACCELERATOR HS-CODE(S) 90221400 BAL ECB ANR2225066 | 45 PKG |