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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
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