Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New Model Variant)

System, Radiation Therapy, Radionuclide

Elekta Solutions AB

The following data is part of a premarket notification filed by Elekta Solutions Ab with the FDA for Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (new Model Variant).

Pre-market Notification Details

Device IDK222047
510k NumberK222047
Device Name:Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New Model Variant)
ClassificationSystem, Radiation Therapy, Radionuclide
Applicant Elekta Solutions AB Kungstensgatan 18 Box 7593 Stockholm,  SE SE-10393
ContactHelena Skar
CorrespondentHelena Skar
Elekta Solutions AB Kungstensgatan 18 Box 7593 Stockholm,  SE SE-10393
Product CodeIWB  
CFR Regulation Number892.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-12
Decision Date2022-10-26

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