Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon

System, Radiation Therapy, Radionuclide

Elekta Instrument AB

The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon.

Pre-market Notification Details

Device IDK173789
510k NumberK173789
Device Name:Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon
ClassificationSystem, Radiation Therapy, Radionuclide
Applicant Elekta Instrument AB Kungstensgatan 18 Stockholm,  SE 10393
ContactAlf Laurell
CorrespondentAlf Laurell
Elekta Instrument AB Kungstensgatan 18 Stockholm,  SE 10393
Product CodeIWB  
CFR Regulation Number892.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-14
Decision Date2018-03-30
Summary:summary

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