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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 K241524
Device Name Elucid PlaqueIQ
Applicant
Elucid Bioimaging, Inc.
2 Park Plaza
Suite 700
Boston,  MA  02116
Applicant Contact Hiral Vora
Correspondent
Elucid Bioimaging, Inc.
399 Boylston Street
Suite 400
Boston,  MA  02116
Correspondent Contact Hiral Vora
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/29/2024
Decision Date 09/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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