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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
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