Quantib AI Node

System, Image Processing, Radiological

Quantib BV

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

Pre-market Notification Details

Device IDK200899
510k NumberK200899
Device Name:Quantib AI Node
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 Received2020-04-03
Decision Date2020-06-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08719689791049 K200899 000
08719689791100 K200899 000
08719689791124 K200899 000
08719689791162 K200899 000
08719689791193 K200899 000
08719689791247 K200899 000
08719689791285 K200899 000

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