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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K241430
Device Name EchoMeasure
Applicant
Icardio.Ai
1875 Century Park E.
Suite 1800
Los Angeles,  CA  90067
Applicant Contact Roman Sandler
Correspondent
Icardio.Ai
1875 Century Park E.
Suite 1800
Los Angeles,  CA  90067
Correspondent Contact Roman Sandler
Regulation Number892.2050
Classification Product Code
QIH  
Date Received05/21/2024
Decision Date 10/10/2024
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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