LEKSELL GAMMAPLAN

System, Planning, Radiation Therapy Treatment

ELEKTA INSTRUMENT AB

The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Gammaplan.

Pre-market Notification Details

Device IDK090972
510k NumberK090972
Device Name:LEKSELL GAMMAPLAN
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 Stockholm,  SE S-103 93
ContactAnders Skoglund
CorrespondentAnders Skoglund
ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 Stockholm,  SE S-103 93
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-06
Decision Date2009-07-20
Summary:summary

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