RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review

System, Planning, Radiation Therapy Treatment

Brainlab AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Rt Elements, Cranial Srs, Spine Srs, Multiple Brain Mets Srs, Rt Qa, Adaptive Hybrid Surgery Analysis, Dose Review.

Pre-market Notification Details

Device IDK190664
510k NumberK190664
Device Name:RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant Brainlab AG Olof-Palme-Str. 9 München,  DE 81829
ContactRainer Birkenbach
CorrespondentAlexander Schwiersch
Brainlab AG Olof-Palme-Str. 9 München,  DE 81829
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-15
Decision Date2019-04-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056481142094 K190664 000

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