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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 7 of 7 Results
ProductCode: IYE Applicant: Elekta Limited Decision Date To: 05/17/2024
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elekta synergy, elekta harmony, elekta infinity, versa hd Elekta Limited K210500 06/11/2021
elekta unity Elekta Limited K192482 12/05/2019
synergy platform, synergy, infinity, versahd Elekta Limited K192242 11/22/2019
elekta unity Elekta Limited K182076 12/04/2018
iviewdose r1.0 Elekta Limited K153011 12/11/2015
xvi r5.0 Elekta Limited K131965 09/25/2013
integrity(tm) Elekta Limited K112613 12/16/2011
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