Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update

Neurological Stereotaxic Instrument

Brainlab AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software Ent, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (bk), Intraoperative Structure Update.

Pre-market Notification Details

Device IDK192703
510k NumberK192703
Device Name:Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update
ClassificationNeurological Stereotaxic Instrument
Applicant Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
ContactChiara Cunico
CorrespondentChiara Cunico
Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-27
Decision Date2020-10-08

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