Elekta Unity

Accelerator, Linear, Medical

Elekta Solutions AB

The following data is part of a premarket notification filed by Elekta Solutions Ab with the FDA for Elekta Unity.

Pre-market Notification Details

Device IDK212114
510k NumberK212114
Device Name:Elekta Unity
ClassificationAccelerator, Linear, Medical
Applicant Elekta Solutions AB Kungstensgatan 18 Box 7593 Stockholm,  SE Se10393
ContactMelinda Smith
CorrespondentMelinda Smith
Elekta, Inc. 400 Perimeter Center Ter NE Suite 50 Atlanta,  GA  30346
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-07
Decision Date2021-10-01

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