MODEIFICATION TO IPLAN RT DOSE

System, Planning, Radiation Therapy Treatment

BRAINLAB AG

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

Pre-market Notification Details

Device IDK080888
510k NumberK080888
Device Name:MODEIFICATION TO IPLAN RT DOSE
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen,  DE 85622
ContactCarsten Raupach
CorrespondentCarsten Raupach
BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen,  DE 85622
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-31
Decision Date2008-06-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056481138608 K080888 000
04056481000592 K080888 000

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