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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 K232613
Device Name CT Cardiomegaly
Applicant
Innolitics, LLC
1101 West 34th St
Austin,  TX  78705
Applicant Contact Yujan Shrestha
Correspondent
Innolitics, LLC
1101 West 34th St
Austin,  TX  78705
Correspondent Contact Meritxell Martinez
Regulation Number892.2050
Classification Product Code
QIH  
Date Received08/28/2023
Decision Date 02/28/2024
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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