Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD

Accelerator, Linear, Medical

Elekta Limited

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

Pre-market Notification Details

Device IDK210500
510k NumberK210500
Device Name:Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
ClassificationAccelerator, Linear, Medical
Applicant Elekta Limited Linac House, Fleming Way Crawley,  GB Rh10 9rr
ContactLorenzo Muratori
CorrespondentLorenzo Muratori
Elekta, Inc. Linac House, Fleming Way, Crawley, West Sussex,RH10 9RR GB
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-22
Decision Date2021-06-11

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