Synergy Platform, Synergy, Infinity, VersaHD

Accelerator, Linear, Medical

Elekta Limited

The following data is part of a premarket notification filed by Elekta Limited with the FDA for Synergy Platform, Synergy, Infinity, Versahd.

Pre-market Notification Details

Device IDK192242
501k NumberK192242
Device Name:Synergy Platform, Synergy, Infinity, VersaHD
ClassificationAccelerator, Linear, Medical
Applicant Elekta Limited Linac House Fleming Way Crawley,  GB Rh10 9rr
ContactIrina Proutski
CorrespondentIrina Proutski
Elekta Limited Linac House Fleming Way Crawley,  GB Rh10 9rr
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
501k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-19
Decision Date2019-11-22

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