RT Elements, Cranial SRS W/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, 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 W/ Cones, Multiple Brain Mets Srs, Cranial Srs, Spine Srs, Rt Qa, Dose Review.

Pre-market Notification Details

Device IDK203681
510k NumberK203681
Device Name:RT Elements, Cranial SRS W/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
ContactChiara Cunico
CorrespondentChiara Cunico
Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-17
Decision Date2021-04-09

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.