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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 K183012
Device Name vascuCAP
Applicant
Elucid Bioimaging Inc.
225 Main Street
Wenham,  MA  01984
Applicant Contact Andrew Buckler
Correspondent
Elucid Bioimaging Inc.
225 Main Street
Suite 15
Wenham,  MA  01984
Correspondent Contact Andrew Buckler
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/31/2018
Decision Date 12/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Clinical Trials NCT02143102
Reviewed by Third Party No
Combination Product No
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