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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 K203256
Device Name Imbio RV/LV Software
Applicant
Imbio, LLC
1015 Glenwood Avenue, Floor 4
Minneapolis,  MN  55405
Applicant Contact William McLain
Correspondent
Imbio, LLC
1015 Glenwood Avenue, Floor 4
Minneapolis,  MN  55405
Correspondent Contact William McLain
Regulation Number892.2050
Classification Product Code
QIH  
Date Received11/04/2020
Decision Date 03/09/2021
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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