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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 K241847
Device Name Imbio PHA (4.0.0)
Applicant
Imbio, Inc.
1015 Glenwood Ave.
Floor 4
Minneapolis,  MN  55405
Applicant Contact Lauren Keith
Correspondent
Imbio, Inc.
1015 Glenwood Ave.
Floor 4
Minneapolis,  MN  55405
Correspondent Contact Lauren Keith
Regulation Number892.2050
Classification Product Code
QIH  
Date Received06/26/2024
Decision Date 08/30/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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