INTUITION IMAGE

System, Radiation Therapy, Charged-particle, Medical

BRAINLAB, AG

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

Pre-market Notification Details

Device IDK032511
510k NumberK032511
Device Name:INTUITION IMAGE
ClassificationSystem, Radiation Therapy, Charged-particle, Medical
Applicant BRAINLAB, AG AMMERTHALSTRASSE 8 Heimstetten,  DE 85551
ContactRainer Birkenbach
CorrespondentRainer Birkenbach
BRAINLAB, AG AMMERTHALSTRASSE 8 Heimstetten,  DE 85551
Product CodeLHN  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-14
Decision Date2004-01-21
Summary:summary

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