Libby IAAA V1.0

System, Image Processing, Radiological

Dyad Medical, Inc.

The following data is part of a premarket notification filed by Dyad Medical, Inc. with the FDA for Libby Iaaa V1.0.

Pre-market Notification Details

Device IDK210931
510k NumberK210931
Device Name:Libby IAAA V1.0
ClassificationSystem, Image Processing, Radiological
Applicant Dyad Medical, Inc. 215 Brighton Avenue, Suite 203 Boston,  MA  02134
ContactRonny Shalev
CorrespondentRory A. Carrillo
Dyad Medical, Inc. 215 Brighton Avenue, Suite 203 Boston,  MA  02134
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-29
Decision Date2021-12-17

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