Quantib Brain 1.2

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 1.2.

Pre-market Notification Details

Device IDK163013
510k NumberK163013
Device Name:Quantib Brain 1.2
ClassificationSystem, Image Processing, Radiological
Applicant Quantib BV Westblaak 106 Rotterdam,  NL 3012km
ContactRudolf Scholte
CorrespondentRudolf Scholte
Quantib BV Westblaak 106 Rotterdam,  NL 3012km
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-28
Decision Date2017-01-06
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.