Brainomix 360 E-CTA

System, Image Processing, Radiological

Brainomix Limited

The following data is part of a premarket notification filed by Brainomix Limited with the FDA for Brainomix 360 E-cta.

Pre-market Notification Details

Device IDK192692
510k NumberK192692
Device Name:Brainomix 360 E-CTA
ClassificationSystem, Image Processing, Radiological
Applicant Brainomix Limited Suites 11-14 Suffolk House, 263 Banbury Road Oxford,  GB Ox2 7hn
ContactGwilym Owen
CorrespondentGwilym Owen
Brainomix Limited Suites 11-14 Suffolk House, 263 Banbury Road Oxford,  GB Ox2 7hn
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-26
Decision Date2020-05-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B720BX360ECTA1110 K192692 000

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