Elekta Limited

FDA Filings

This page includes the latest FDA filings for Elekta Limited. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Elekta Limited
Elekta Unity2019-12-05
Elekta Limited
Synergy Platform, Synergy, Infinity, VersaHD2019-11-22
Elekta Instrument AB
Leksell Vantage Stereotactic System2019-08-01
Elekta, Inc.
Monaco RTP System2019-03-29
Elekta, Inc
Monaco RTP System2018-12-04
Elekta, Inc
MOSAIQ Oncology Information System2018-12-04
Elekta Limited
Elekta Unity2018-12-04
Elekta Instrument AB
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon2018-03-30
Elekta Instrument AB
Leksell GammaPlan2018-02-09
ELEKTA INSTRUMENT AB
Leksell Stereotactic System, Injection/ Aspiration Needle Kit2016-03-02
ELEKTA INSTRUMENT AB
Leksell Gamma Knife Perfexion2015-10-29
ELEKTA LTD.
CLARITY2014-10-08
Elekta Limited
XVI R5.02013-09-25
Elekta Limited
INTEGRITY(TM)2011-12-16
Elekta Limited
APEX2011-09-30
ELEKTA NEUROMAG OY
ELEKTA NEUROMAG WITH MAXFILTER2010-10-26
ELEKTA NEUROMAG OY
ELEKTA OY2004-08-10
ELEKTA ONCOLOGY SYSTEMS, INC.
ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS1997-12-17

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
MOSAIQ
ELEKTA, INC.2019-11-08
Leksell Gamma Knife Icon
Elekta Instrument AB2019-11-01
Leksell Gamma Knife Icon
Elekta Instrument AB2019-11-01
Leksell Gamma Knife Icon
Elekta Instrument AB2019-11-01
Leksell Gamma Knife Icon
Elekta Instrument AB2019-11-01
Monaco
ELEKTA, INC.2019-10-25
Leksell Gamma Knife Icon
Elekta Instrument AB2019-10-23
Leksell Vantage Stereotactic System
Elekta Instrument AB2019-09-18
Leksell Vantage Stereotactic System
Elekta Instrument AB2019-09-18
Leksell Vantage Stereotactic System
Elekta Instrument AB2019-09-18
Leksell Vantage Stereotactic System
Elekta Instrument AB2019-09-18
Leksell Vantage Stereotactic System
Elekta Instrument AB2019-09-18
Leksell Vantage Stereotactic System
Elekta Instrument AB2019-09-18
MOSAIQ
ELEKTA, INC.2019-06-06
Monaco
ELEKTA, INC.2019-05-31
Elekta Unity
ELEKTA LIMITED2019-05-08
Elekta Unity
ELEKTA LIMITED2019-05-08
Leksell Gamma Knife Perfexion/Icon
Elekta Instrument AB2019-04-25
Monaco
ELEKTA, INC.2019-04-05
Clarity®
Elekta Ltd2019-04-04
MOSAIQ
ELEKTA, INC.2019-03-14
MOSAIQ
ELEKTA, INC.2019-03-14
MOSAIQ
ELEKTA, INC.2019-03-14
MOSAIQ
ELEKTA, INC.2019-03-14
ERGO Localizer
ELEKTA, INC.2019-03-13
ERGO++
ELEKTA, INC.2019-03-13
Monaco
ELEKTA, INC.2019-03-13
Monaco
ELEKTA, INC.2019-03-13
Monaco
ELEKTA, INC.2019-03-13
Monaco
ELEKTA, INC.2019-03-13
XiO
ELEKTA, INC.2019-03-13
Monaco
ELEKTA, INC.2019-03-13
Atlas-Based Autosegmentation
ELEKTA, INC.2019-03-13
Elekta Unity
ELEKTA LIMITED2019-02-25
Clarity®
Elekta Ltd2018-12-20

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