ElucidVivo A.3

System, Image Processing, Radiological

Elucid Bioimaging Inc.

The following data is part of a premarket notification filed by Elucid Bioimaging Inc. with the FDA for Elucidvivo A.3.

Pre-market Notification Details

Device IDK221463
510k NumberK221463
Device Name:ElucidVivo A.3
ClassificationSystem, Image Processing, Radiological
Applicant Elucid Bioimaging Inc. 2 Park Plaza, Suite 700 Boston,  MA  02116
ContactDoug Shufelt
CorrespondentDoug Shufelt
Elucid Bioimaging Inc. 2 Park Plaza, Suite 700 Boston,  MA  02116
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-19
Decision Date2022-06-17

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