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 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:
  • Thomas Valentine
  • Elekta, Inc.
  • 404 7972537
  • Thomas.Valentine@elekta.com
• 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

FDA Filings

Device Company	Device	Date
GUDID 07340201501511 Elekta Solutions AB	Leksell Vantage Stereotactic System	2024-09-09
GUDID 07340201501887 Elekta Solutions AB	Leksell Vantage Stereotactic System	2024-08-22
GUDID 07340201501337 Elekta Solutions AB	Leksell Vantage Stereotactic System 1040035	2024-08-14
GUDID 07340201501313 Elekta Solutions AB	Leksell Vantage Stereotactic System 1040034	2024-08-13
GUDID 07340201501290 Elekta Solutions AB	Leksell Vantage Stereotactic System 1040033	2024-08-13
GUDID 07340201501276 Elekta Solutions AB	Leksell Vantage Stereotactic System 1040032	2024-07-12
GUDID 07340201501252 Elekta Solutions AB	Leksell Vantage Stereotactic System 1040031	2024-07-12
GUDID 07340201501757 Elekta Solutions AB	Leksell Vantage Stereotactic System 1040100	2024-06-28
GUDID 07340201501719 Elekta Solutions AB	Leksell Vantage Stereotactic System 1040096	2024-06-28
GUDID 07340201501658 Elekta Solutions AB	Leksell Vantage Stereotactic System 1040093	2024-06-28
GUDID 07340201501634 Elekta Solutions AB	Leksell Vantage Stereotactic System 1040090	2024-06-28
GUDID 07340201501382 Elekta Solutions AB	Leksell Vantage Stereotactic System 1040014	2024-06-26
GUDID 07340048306065 Elekta Solutions AB	Leksell Vantage Stereotactic System 1040027	2024-06-26
GUDID 07340201501832 Elekta Solutions AB	Leksell Vantage Stereotactic System 1040110	2024-06-25
GUDID 07340201501764 Elekta Solutions AB	Leksell Vantage Stereotactic System 1040114	2024-06-25
GUDID 07340201501535 Elekta Solutions AB	Leksell Vantage Stereotactic System 1040045	2024-06-25
GUDID 07340201501825 Elekta Solutions AB	Leksell Vantage Stereotactic System 1040036	2024-06-19
GUDID 07340201502198 Elekta Solutions AB	Leksell Vantage Stereotactic System 1040036	2024-06-07
GUDID 07340201500057 Elekta Solutions AB	ProKnow DS	2024-03-29
GUDID 07340201502136 Elekta Solutions AB	Leksell GammaPlan	2024-02-22
GUDID 07540180000221 Elekta Solutions AB	Clarity®	2023-06-30
GUDID 07340201500071 Elekta Solutions AB	MOSAIQ	2023-04-12
GUDID 07340201500064 Elekta Solutions AB	Monaco	2023-04-12
GUDID 07340201501139 Elekta Solutions AB	Leksell Gamma Knife Esprit	2023-04-04
PMN K222047 Elekta Solutions AB	Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New Model Variant)	2022-10-26
GUDID 07340201500033 Elekta Solutions AB	Monaco	2022-07-19
GUDID 07340201500040 Elekta Solutions AB	AATMA	2022-03-17
PMN K212114 Elekta Solutions AB	Elekta Unity	2021-10-01
GUDID 07340201500026 Elekta Solutions AB	MOSAIQ	2021-08-24
GUDID 05060191071604 Elekta Solutions AB	Elekta Medical Linear Accelerator	2021-08-09
GUDID 05060191071581 Elekta Solutions AB	Elekta Medical Linear Accelerator	2021-08-09
GUDID 05060191071574 Elekta Solutions AB	Elekta Medical Linear Accelerator	2021-08-09
GUDID 05060191071550 Elekta Solutions AB	Elekta Medical Linear Accelerator	2021-08-09
GUDID 05060191071543 Elekta Solutions AB	Elekta Medical Linear Accelerator	2021-08-09
GUDID 05060191071529 Elekta Solutions AB	Elekta Medical Linear Accelerator	2021-08-09
GUDID 05060191071512 Elekta Solutions AB	Elekta Medical Linear Accelerator	2021-08-09
GUDID 05060191071505 Elekta Solutions AB	Elekta Medical Linear Accelerator	2021-08-09
PMN K203172 Elekta Solutions AB	MOSAIQ Oncology Information System	2020-12-18
PMN K183037 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	Monaco	2018-12-05
PMN K183037 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	Monaco RTP System	2018-12-05
PMN K183034 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	MOSAIQ	2018-12-05
PMN K183034 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	MOSAIQ Oncology Information System	2018-12-05
PMN K182076 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Unity	2018-12-05
PMN K182076 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Unity MR-linac	2018-12-05
PMN K182076 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Marlin 1.5T	2018-12-05
PMN K182076 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Elekta Unity	2018-12-05
PMN K173789 | IWB ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Gamma Knife	2018-10-16
PMN K121530 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	BodyFIX System	2018-10-15
PMN K173791 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Gamma Plan 11.1	2018-02-12
PMN K173791 | IWB ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Gamma Plan 11.1	2018-02-12
PMN K171123 | HAW ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Vantage Stereotactic System	2017-12-06
PMN K161688 | JAQ ELEKTA SOLUTIONS AB [ELEKTA AB]	Advanced Gynecological Applicator	2017-01-30
PMN K153011 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	iViewDose	2016-12-07
PMN K160440 | IWB ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Gamma Knife? Icon?	2016-04-29
PMN K151159 | IWB ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Gamma Knife Perfexion	2016-04-01
PMN K152558 | HAW ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Stereotactic System?	2016-03-03
PMN K151666 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell GammaPlan?	2016-02-26
PMN K151561 | IWB ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Gamma Knife? Icon?	2016-02-26
PMN K131965 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Synergy XVI	2015-12-03
PMN K123808 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Integrity 3.1	2015-12-03
PMN K151233 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	Monaco RTP System	2015-07-23
PMN K973936 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	XiO RTP System	2015-04-27
PMN K973936 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Focus RTP System	2015-04-27
PMN K141572 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	MOSAIQ Oncology Information System	2015-04-27
PMN K141572 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	MOSAIQ Oncology Information System	2015-04-27
PMN K132971 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	Monaco RTP System	2015-04-27
PMN K123230 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	MOSAIQ Oncology Information System	2015-04-27
PMN K110730 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	Monaco RTP System	2015-04-27
PMN K102216 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	XiO RTP System	2015-04-27
PMN K092132 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	XiO RTP System	2015-04-27
PMN K091179 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	Monaco RTP System	2015-04-27
PMN K032762 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	XiO RTP System	2015-04-27
PMN K032762 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	XiO RTP System	2015-04-27
PMN K031281 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	Ergo++	2015-04-27
PMN K020027 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	XiO RTP System	2015-04-27
PMN K020027 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	Focus RTP System	2015-04-27
PMN K013112 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	Focal Workstation	2015-04-27
PMN K002147 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	XiO RTP System	2015-04-27
PMN K002147 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	Focus RTP System	2015-04-27
PMN K972398 | HAW ELEKTA SOLUTIONS AB [ELEKTA AB]	STEALTHSTATION PASSIVE INSTRUMENT OPTION	2012-12-04
PMN K972398 | HAW ELEKTA SOLUTIONS AB [ELEKTA AB]	INST 960-539 GUIDE, BIOPSY	2012-12-04
PMN K050438 | HAW ELEKTA SOLUTIONS AB [ELEKTA AB]	STEALTHSTATION SYSTEM UPDATE	2012-12-04
PMN K050438 | HAW ELEKTA SOLUTIONS AB [ELEKTA AB]	ARM 9734252 VERTEK II	2012-12-04
PMN K121328 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Agility	2012-10-24
PMN K120811 | IWB ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Gamma Knife Perfexion	2012-10-19
PMN K112210 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Fraxion	2012-05-18
PMN K120067 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	MOSAIQ Oncology Information System	2012-03-05
PMN K112613 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	INTEGRITY	2012-02-03
PMN K111676 | IXI ELEKTA SOLUTIONS AB [ELEKTA AB]	APEX	2012-02-03
PMN K100115 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	XVI 4.5	2012-02-03
PMN K082122 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	MLCi2	2012-02-03
PMN K103093 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell GammaPlan	2011-12-14
PMN K092083 | IWB ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell GammaKnife Perfexion	2009-12-01
PMN K090972 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell GammaPlan	2009-12-01
PMN K080355 | HAW ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Stereotactic System	2009-12-01
PMN K080601 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	ERGO++	2009-05-12
LMB ELEKTA SOLUTIONS AB [ELEKTA AB]	MOSAIQ Oncology PACS	2009-01-07
LMB ELEKTA SOLUTIONS AB [ELEKTA AB]	MOSAIQ Data Director	2009-01-07
JQP ELEKTA SOLUTIONS AB [ELEKTA AB]	MOSAIQ Instrument Manager	2009-01-07
JQP ELEKTA SOLUTIONS AB [ELEKTA AB]	MOSAIQ ESI:Lab Instrument Interface	2009-01-07
PMN K080799 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	Atlas-based Autosegmantation	2008-12-12
PMN K080799 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	ABAS	2008-12-12
PMN K080799 | LHN ELEKTA SOLUTIONS AB [ELEKTA AB]	Atlas-based Autosegmantation	2008-12-12
PMN K080799 | LHN ELEKTA SOLUTIONS AB [ELEKTA AB]	ABAS	2008-12-12
PMN K011255 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Stereotactic Cones	2008-12-11
PMN K011255 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Stereotactic Collimator	2008-12-11
PMN K011255 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Stereotactic Circular Collimator	2008-12-11
PMN K011255 | HAW ELEKTA SOLUTIONS AB [ELEKTA AB]	Stereotactic Cones	2008-12-11
PMN K011255 | HAW ELEKTA SOLUTIONS AB [ELEKTA AB]	Stereotactic Collimator	2008-12-11
PMN K011255 | HAW ELEKTA SOLUTIONS AB [ELEKTA AB]	Stereotactic Circular Collimator	2008-12-11
PMN K984328 | IWB ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Gamma Knife	2008-11-19
PMN K080250 | HAW ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell SurgiPlan	2008-11-19
PMN K063512 | IWB ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Gamma Knife Perfexion	2008-11-19
PMN K061941 | IWB ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Gamma Knife Perfexion	2008-11-19
PMN K061540 | IWB ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Gamma Plan	2008-11-19
PMN K051746 | LHN ELEKTA SOLUTIONS AB [ELEKTA AB]	Elekta Esarte Frame System	2008-11-19
PMN K051746 | HAW ELEKTA SOLUTIONS AB [ELEKTA AB]	Elekta Esarte Frame System	2008-11-19
PMN K051022 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Gamma Plan	2008-11-19
PMN K051022 | IWB ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Gamma Plan	2008-11-19
PMN K042269 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Gamma Plan	2008-11-19
PMN K040979 | HAW ELEKTA SOLUTIONS AB [ELEKTA AB]	Elekta Microdrive	2008-11-19
PMN K033340 | HAW ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell SurgiPlan	2008-11-19
PMN K031999 | HAW ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Stereotactic System	2008-11-19
PMN K031980 | HAW ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell Stereotactic System	2008-11-19
PMN K013861 | HAW ELEKTA SOLUTIONS AB [ELEKTA AB]	Leksell SurgiPlan	2008-11-19
PMN K981535 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	FOCAL	2008-08-01
PMN K915691 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	FOCUS/XiO	2008-08-01
PMN K071938 | MUJ ELEKTA SOLUTIONS AB [ELEKTA AB]	Monaco	2008-08-01
PMN K983678 | JAI ELEKTA SOLUTIONS AB [ELEKTA AB]	Precise Treatment Table	2008-04-10
PMN K983678 | JAI ELEKTA SOLUTIONS AB [ELEKTA AB]	Precise Table	2008-04-10
PMN K963624 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Synergy Platform	2008-04-10
PMN K963624 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Precise Treatment System	2008-04-10
PMN K963624 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Precise Digital Accelerator	2008-04-10
PMN K963624 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Elekta Synergy Platform	2008-04-10
PMN K051932 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	XVI	2008-04-10
PMN K051932 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Versa HD	2008-04-10
PMN K051932 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Synergy	2008-04-10
PMN K051932 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Infinity	2008-04-10
PMN K051932 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Elekta Synergy	2008-04-10
PMN K051932 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Elekta Infinity	2008-04-10
PMN K051932 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Elekta Axesse	2008-04-10
PMN K051932 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	Axesse	2008-04-10
PMN K012289 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	iView GT	2008-04-10
PMN K981313 | IYE ELEKTA SOLUTIONS AB [ELEKTA AB]	SEQUENCER	2007-12-17
PMN K062639 | JAI ELEKTA SOLUTIONS AB [ELEKTA AB]	HEXAPOD COUCH TOP	2006-10-25
FWZ ELEKTA SOLUTIONS AB [ELEKTA AB]	ATLAS INTERVENTION	2005-10-17
IXQ ELEKTA SOLUTIONS AB [ELEKTA AB]	iBEAM, various	2004-10-14
IXQ ELEKTA SOLUTIONS AB [ELEKTA AB]	Unity CT Overlay	2004-10-14
IXQ ELEKTA SOLUTIONS AB [ELEKTA AB]	Elekta Unity CT Overlay	2004-10-14
IXQ ELEKTA SOLUTIONS AB [ELEKTA AB]	Connexion, various	2004-10-14
IWY ELEKTA SOLUTIONS AB [ELEKTA AB]	TARGET POSITIONER UNIT	2001-05-15
IWY ELEKTA SOLUTIONS AB [ELEKTA AB]	HEADFIX AND LOCALIZER	2001-05-15

U.S. Import Records [external site]

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