LEKSELL GAMMA KNIFE PERFEXION

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.

Pre-market Notification Details

Device IDK120811
510k NumberK120811
Device Name:LEKSELL GAMMA KNIFE PERFEXION
ClassificationSystem, Radiation Therapy, Radionuclide
Applicant ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 Stockholm,  SE S-103 93
ContactViveka Wretman
CorrespondentViveka Wretman
ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 Stockholm,  SE S-103 93
Product CodeIWB  
CFR Regulation Number892.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-16
Decision Date2012-05-24
Summary:summary

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