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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 Ave.
Floor 4
Minneapolis,  MN  55405
Applicant Contact William McLain
Correspondent
Imbio, LLC
1015 Glenwood Ave.
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
Predetermined Change
Control Plan Authorized		 No
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