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Elekta Instrument AB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96121863002806883Elekta Instrument AB1N2026-01-01Hagaplan 4 Stockholm SE 11368

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07340048311700Leksell Gamma Knife Perfexion/Icon - FILM HOLDER VANTAGE LGK+1(855)693-5358info.america@elekta.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
958021639520591K984328LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001IWB1999-05-21
958021557209792K190887Leksell Vantage Stereotactic SystemHAW2019-08-01
958021769736125K173791Leksell GammaPlanIWB2018-02-09
958021611158319K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconIWB2018-03-30
958021110230816K171123Leksell Vantage Stereotactic SystemHAW2017-09-15
958021377537470K160440Leksell Gamma Knife IconIWB2016-04-20
958021299668840K152558Leksell Stereotactic System, Injection/ Aspiration Needle KitHAW2016-03-02
958021603264081K151666Leksell GammaPlanMUJ2015-09-03
958021317087510K151561Leksell Gamma Knife IconIWB2015-08-04
958021855211004K151159Leksell Gamma Knife PerfexionIWB2015-10-29
958021763623294K120811LEKSELL GAMMA KNIFE PERFEXIONIWB2012-05-24
958021114050655K103093LEKSELL GAMMAPLANMUJ2010-12-21
958021077569890K092083EXTEND FRAME SYSTEM, MODEL 1009633IWB2009-09-22
958021565143677K090972LEKSELL GAMMAPLANMUJ2009-07-20
958021473535801K080355LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWSHAW2009-05-01
958021428165407K080250LEKSELL SURGIPLAN, MODEL 1006947HAW2008-05-13
958021506305756K063512LEKSELL GAMMA KNIFE PERFEXIONIWB2007-03-05
958021356073701K061941
958021919517064K061540LEKSELL GAMMAPLANIWB2006-07-05
958021354883412K051746ELEKTA ESARTE FRAME SYSTEMHAW2005-07-25
958022072100137K051022GAMMAPLANIWB2005-06-01
958021342392648K042269LEKSELL GAMMAPLAN 4C WITH MULTIVIEWMUJ2004-09-08
958021612618354K040979ELEKTA MICRODRIVE, MODEL 916716HAW2004-07-23
958021143047778K033340LEKSELL SURGIPLAN WITH IMAGEMERGEHAW2004-02-12
958021824883781K031999ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KITHAW2003-07-25
958021169205214K031980MODIFICATION TO LEKSELL STEREOTACTIC SYSTEMHAW2003-07-25
958021230967696K013861MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACEHAW2001-12-06
958021974431319
958022022319124
958022071122160

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HAW112019-08-01
IWB112018-03-30
MUJ42015-09-03

PMN#

GUDID#

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