WRDensity By Whiterabbit.ai

Automated Radiological Image Processing Software

Whiterabbit.ai Inc.

The following data is part of a premarket notification filed by Whiterabbit.ai Inc. with the FDA for Wrdensity By Whiterabbit.ai.

Pre-market Notification Details

Device IDK202013
510k NumberK202013
Device Name:WRDensity By Whiterabbit.ai
ClassificationAutomated Radiological Image Processing Software
Applicant Whiterabbit.ai Inc. 3930 Freedom Cir. Ste 101 Santa Clara,  CA  95054
ContactJason Su
CorrespondentJason Su
Whiterabbit.ai Inc. 3930 Freedom Cir. Ste 101 Santa Clara,  CA  95054
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-21
Decision Date2020-10-30

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