IPLAN RT

System, Planning, Radiation Therapy Treatment

BRAINLAB, AG

The following data is part of a premarket notification filed by Brainlab, Ag with the FDA for Iplan Rt.

Pre-market Notification Details

Device IDK103246
510k NumberK103246
Device Name:IPLAN RT
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant BRAINLAB, AG KAPELLENSTRASSE 12 Feldkirchen,  DE 85622
ContactAlexander Schwiersch
CorrespondentAlexander Schwiersch
BRAINLAB, AG KAPELLENSTRASSE 12 Feldkirchen,  DE 85622
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-03
Decision Date2011-03-16
Summary:summary

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