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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 K242552
Device Name Horos Mobile
Applicant
iCat Solutions Ltd
51-59 Rose Lane
Norwich,  GB NR1 1BY
Applicant Contact Georgios Michalopoulos
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Rd
Shrewsbury,  VT  05738
Correspondent Contact Bhoomika Joyappa
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/27/2024
Decision Date 04/08/2025
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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