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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K210931
Device Name Libby IAAA v1.0
Applicant
Dyad Medical, Inc.
215 Brighton Ave.
Suite 203
Boston,  MA  02134
Applicant Contact Ronny Shalev
Correspondent
Dyad Medical, Inc.
215 Brighton Ave.
Suite 203
Boston,  MA  02134
Correspondent Contact Rory A. Carrillo
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/29/2021
Decision Date 12/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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