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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 K232589
Device Name Horos MD™
iCat Solutions Ltd
51-59 Rose Lane
Norwich,  GB NR1 1BY
Applicant Contact Georgios Michalopoulos
Medical Device Academy, Inc.
345 Lincoln Hill Rd
Shrewsbury,  VT  05738
Correspondent Contact Bhoomika Joyappa
Regulation Number892.2050
Classification Product Code
Date Received08/25/2023
Decision Date 01/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No