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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coronary Vascular Physiologic Simulation Software
510(k) Number K262015
Device Name Elucid FFR-IQ (B.1)
Applicant
Elucid Bioimaging, Inc.
399 Boylston St., Suite 400
Boston,  MA  02116
Applicant Contact Windi Hary
Correspondent
Elucid Bioimaging, Inc.
399 Boylston St., Suite 400
Boston,  MA  02116
Correspondent Contact Windi Hary
Regulation Number870.1415
Classification Product Code
PJA  
Date Received06/15/2026
Decision Date 09/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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