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 IDK063512
510k NumberK063512
Device Name:LEKSELL GAMMA KNIFE PERFEXION
ClassificationSystem, Radiation Therapy, Radionuclide
Applicant ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 PO BOX 7593 Stockholm,  SE Se-103 93
ContactAnders Skoglund
CorrespondentAnders Skoglund
ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 PO BOX 7593 Stockholm,  SE Se-103 93
Product CodeIWB  
CFR Regulation Number892.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-20
Decision Date2007-03-05
Summary:summary

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