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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 K221463
Device Name ElucidVivo A.3
Applicant
Elucid Bioimaging, Inc.
2 Park Plaza
Suite 700
Boston,  MA  02116
Applicant Contact Doug Shufelt
Correspondent
Elucid Bioimaging, Inc.
2 Park Plaza
Suite 700
Boston,  MA  02116
Correspondent Contact Doug Shufelt
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/19/2022
Decision Date 06/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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