Quantib Prostate

System, Image Processing, Radiological

Quantib BV

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

Pre-market Notification Details

Device IDK202501
510k NumberK202501
Device Name:Quantib Prostate
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 Received2020-08-31
Decision Date2020-10-11

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