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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 K261405
Device Name ANDI 2.2
Applicant
Imeka Solutions, Inc.
195, Belvédère Nord
Sherbrooke,  CA J1H4A7
Applicant Contact Valerie Lacroix
Correspondent
Eversana
7045 College Blvd.
Overland Park,  KS  66211
Correspondent Contact Kory Dillman
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received04/29/2026
Decision Date 05/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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