Elekta Inc

FDA Filings

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

Elekta Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1937649
FEI Number1937649
NameElekta, Inc.
Owner & OperatorELEKTA AB
Contact AddressKUNGSTENSGATAN 18 Box 7593
STOCKHOLM SE-AB Stockholms lan [SE-01] SE10393 SE
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1450 Beale Street, Suite 205
Saint Charles, MO 63303 US
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

Registration Number1037831
FEI Number1037831
NameELEKTA, INC
Owner & OperatorELEKTA AB
Contact AddressKUNGSTENSGATAN 18 Box 7593
STOCKHOLM SE-AB Stockholms lan [SE-01] SE10393 SE
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address400 Perimeter Center Ter NE Suite 50
Atlanta, GA 30346 US
Establishment TypeManufacture Medical Device

Registration Number2950347
FEI Number1000123805
NameElekta, INC.
Owner & OperatorELEKTA AB
Contact AddressKUNGSTENSGATAN 18 Box 7593
STOCKHOLM SE-AB Stockholms lan [SE-01] SE10393 SE
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address100 Mathilda Pl Fl 5
SUNNYVALE, CA 94086 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
ELEKTA, INC.
 Aqua 2023-06-30
ELEKTA, INC.
 MOSAIQ 2021-12-10
Elekta, Inc. [ELEKTA AB]
ProKnow DS2020-01-07
ELEKTA, INC.
 MOSAIQ 2019-11-08
ELEKTA, INC.
 Monaco 2019-10-25
ELEKTA, INC.
 MOSAIQ 2019-08-12
ELEKTA, INC.
 MOSAIQ 2019-08-12
ELEKTA, INC.
 ERGO Localizer 2019-08-05
ELEKTA, INC.
 ERGO++ 2019-08-05
ELEKTA, INC.
 Monaco 2019-08-05
ELEKTA, INC.
 Monaco 2019-08-05
ELEKTA, INC.
 Monaco 2019-08-05
ELEKTA, INC.
 Monaco 2019-08-05
ELEKTA, INC.
 XiO 2019-08-05
ELEKTA, INC.
 Atlas-Based Autosegmentation 2019-08-05
ELEKTA, INC.
 MOSAIQ 2019-06-06
ELEKTA, INC.
 Monaco 2019-05-31
ELEKTA, INC.
 Monaco 2019-04-05
Elekta, Inc. [ELEKTA AB]
Monaco2019-04-03
Elekta, Inc.
Monaco RTP System2019-03-29
ELEKTA, INC.
 MOSAIQ 2019-03-14
ELEKTA, INC.
 MOSAIQ 2019-03-14
ELEKTA, INC.
 Monaco 2019-03-13
Elekta, Inc. [ELEKTA AB]
Monaco2018-12-05
Elekta, Inc. [ELEKTA AB]
Monaco RTP System2018-12-05
Elekta, INC. [ELEKTA AB]
MOSAIQ2018-12-05
Elekta, INC. [ELEKTA AB]
MOSAIQ Oncology Information System2018-12-05
Elekta, Inc
Monaco RTP System2018-12-04
Elekta, Inc
MOSAIQ Oncology Information System2018-12-04
ELEKTA, INC [ELEKTA AB]
Advanced Gynecological Applicator2017-01-30
Elekta, Inc. [ELEKTA AB]
Monaco RTP System2015-07-23
Elekta, Inc. [ELEKTA AB]
XiO RTP System2015-04-27
Elekta, Inc. [ELEKTA AB]
Focus RTP System2015-04-27
Elekta, INC. [ELEKTA AB]
MOSAIQ Oncology Information System2015-04-27
Elekta, INC. [ELEKTA AB]
MOSAIQ Oncology Information System2015-04-27
Elekta, Inc. [ELEKTA AB]
Monaco RTP System2015-04-27
Elekta, INC. [ELEKTA AB]
MOSAIQ Oncology Information System2015-04-27
Elekta, Inc. [ELEKTA AB]
Monaco RTP System2015-04-27
Elekta, Inc. [ELEKTA AB]
XiO RTP System2015-04-27
Elekta, Inc. [ELEKTA AB]
XiO RTP System2015-04-27
Elekta, Inc. [ELEKTA AB]
Monaco RTP System2015-04-27
Elekta, Inc. [ELEKTA AB]
XiO RTP System2015-04-27
Elekta, Inc. [ELEKTA AB]
XiO RTP System2015-04-27
Elekta, Inc. [ELEKTA AB]
Ergo++2015-04-27
Elekta, Inc. [ELEKTA AB]
XiO RTP System2015-04-27
Elekta, Inc. [ELEKTA AB]
Focus RTP System2015-04-27
Elekta, Inc. [ELEKTA AB]
Focal Workstation2015-04-27
Elekta, Inc. [ELEKTA AB]
XiO RTP System2015-04-27
Elekta, Inc. [ELEKTA AB]
Focus RTP System2015-04-27
ELEKTA INC. D/B/A NUCLETRON CORPORATION
ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY2012-07-02
Elekta, INC. [ELEKTA AB]
MOSAIQ Oncology Information System2012-03-05
Elekta, Inc. [ELEKTA AB]
ERGO++2009-05-12
Elekta, INC. [ELEKTA AB]
MOSAIQ Oncology PACS2009-01-07
Elekta, INC. [ELEKTA AB]
MOSAIQ Data Director2009-01-07
Elekta, INC. [ELEKTA AB]
MOSAIQ Instrument Manager2009-01-07
Elekta, INC. [ELEKTA AB]
MOSAIQ ESI:Lab Instrument Interface2009-01-07
Elekta, Inc. [ELEKTA AB]
Atlas-based Autosegmantation2008-12-12
Elekta, Inc. [ELEKTA AB]
ABAS2008-12-12
Elekta, Inc. [ELEKTA AB]
Atlas-based Autosegmantation2008-12-12
Elekta, Inc. [ELEKTA AB]
ABAS2008-12-12
Elekta, Inc. [ELEKTA AB]
FOCAL2008-08-01
Elekta, Inc. [ELEKTA AB]
FOCUS/XiO2008-08-01
Elekta, Inc. [ELEKTA AB]
Monaco2008-08-01
Elekta, INC. [ELEKTA AB]
SEQUENCER2007-12-17
ELEKTA, INC
ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.52005-08-12

Similar & Related FDA Registered Companies

Related Finance Registrations
NCAGE Code1LKD8ELEKTA, INC.!DBA ELEKTA
CAGE Code1LKD8ELEKTA, INC. ELEKTA
S.A.M. Registration1LKD8 [102014008]ELEKTA, INC. ELEKTA
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091622097Stadersand,Federal Republic of Germany -> Savannah, GeorgiaOEELSELL GAMMA KNIFE DEMONSTARION UNIT AND AS .6 PKG
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
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