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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 K242062
Device Name 1CMR Pro
Applicant
Mycardium AI Limited
The Spine, 2 Paddington Village
Liverpool,  GB L73FA
Applicant Contact Michael Walker
Correspondent
Hardian Ltd T/A Hardian Health
C/O Galloways, 3rd Floor 21 Perrymount Rd.
Haywards Heath,  GB RH16 3TP
Correspondent Contact Michael Pogose
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
QIH  
Date Received07/15/2024
Decision Date 11/15/2024
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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