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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image Acquisition And/Or Optimization Guided By Artificial Intelligence
510(k) Number K243065
Device Name Cardiac Guidance
Applicant
Caption Health, Inc.
4 W. 4th Ave.
Suite 215
San Mateo,  CA  94402
Applicant Contact Tahir Rizvi
Correspondent
Caption Health, Inc.
4 W. 4th Ave.
Suite 215
San Mateo,  CA  94402
Correspondent Contact Tahir Rizvi
Classification Product Code
QJU  
Date Received09/27/2024
Decision Date 01/15/2025
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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