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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 K230913
Device Name ANDI
Applicant
Imeka Solutions, Inc.
195, Belvedere Nord
#201
Sherbrooke,  CA J1H 4A7
Applicant Contact Valerie Lacroix
Correspondent
Imeka Solutions, Inc.
195, Belvedere Nord
#201
Sherbrooke,  CA J1H 4A7
Correspondent Contact Valerie Lacroix
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received03/31/2023
Decision Date 07/25/2023
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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