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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 13 Results
ProductCode: IWB Applicant: ELEKTA INSTRUMENT AB Decision Date To: 05/22/2024
 
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510(K)
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leksell gamma knife perfexion, leksell gamma knife icon Elekta Instrument AB K173789 03/30/2018
leksell gammaplan Elekta Instrument AB K173791 02/09/2018
leksell gamma knife icon Elekta Instrument AB K160440 04/20/2016
leksell gamma knife perfexion ELEKTA INSTRUMENT AB K151159 10/29/2015
leksell gamma knife icon ELEKTA INSTRUMENT AB K151561 08/04/2015
leksell gamma knife perfexion ELEKTA INSTRUMENT AB K133565 05/09/2014
leksell gamma knife perfexion ELEKTA INSTRUMENT AB K120811 05/24/2012
extend frame system, model 1009633 ELEKTA INSTRUMENT AB K092083 09/22/2009
leksell gamma knife perfexion ELEKTA INSTRUMENT AB K063512 03/05/2007
leksell gamma knife perfexion, model 715000 ELEKTA INSTRUMENT AB K061941 08/21/2006
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