Libby Echo:Prio

Automated Radiological Image Processing Software

Dyad Medical, Inc

The following data is part of a premarket notification filed by Dyad Medical, Inc with the FDA for Libby Echo:prio.

Pre-market Notification Details

Device IDK220956
510k NumberK220956
Device Name:Libby Echo:Prio
ClassificationAutomated Radiological Image Processing Software
Applicant Dyad Medical, Inc 215 Brighton Avenue, Suite 203 Boston,  MA  02134
ContactRonny Shalev
CorrespondentYervant Chijian
Pharmalex Pty Ltd Suite 10.4, 1 Chandos Street St. Leonards,  AU 2068
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-01
Decision Date2022-07-20

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