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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
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