Quantib Brain

System, Image Processing, Radiological

Quantib BV

The following data is part of a premarket notification filed by Quantib Bv with the FDA for Quantib Brain.

Pre-market Notification Details

Device IDK173939
510k NumberK173939
Device Name:Quantib Brain
ClassificationSystem, Image Processing, Radiological
Applicant Quantib BV Westblaak 106 Rotterdam,  NL 3012 Km
ContactFloor Van Leeuwen
CorrespondentFloor Van Leeuwen
Quantib BV Westblaak 106 Rotterdam,  NL 3012 Km
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-26
Decision Date2018-03-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08719689791070 K173939 000

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