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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 K250670
Device Name EchoConfidence (USA)
Applicant
Mycardium AI Limited
The Spine, 2 Paddington Village
Liverpool,  GB L73FA
Applicant Contact Michael Walker
Correspondent
Hardian Health Ltd T/A Hardian Health
C/O Galloways, 3rd Floor 21 Perrymount Rd.
Haywards Heath,  GB RH16 3T
Correspondent Contact Michael Pogose
Regulation Number892.2050
Classification Product Code
QIH  
Date Received03/05/2025
Decision Date 06/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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