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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 K240793
Device Name MSKai
Applicant
Mskai
6075 Poplar
Suite 221
Memphis,  TN  38119
Applicant Contact Wade Lloyd
Correspondent
Mskai
6075 Poplar
Suite 221
Memphis,  TN  38119
Correspondent Contact Wade Lloyd
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Codes
JAK   LLZ  
Date Received03/22/2024
Decision Date 12/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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