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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name automated radiological image processing software
510(k) Number K220956
Device Name Libby Echo:Prio
Dyad Medical, Inc
215 Brighton Avenue, Suite 203
Boston,  MA  02134
Applicant Contact Ronny Shalev
Pharmalex Pty Ltd
Suite 10.4, 1 Chandos Street
St. Leonards,  AU 2068
Correspondent Contact Yervant Chijian
Regulation Number892.2050
Classification Product Code
Date Received04/01/2022
Decision Date 07/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No