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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K230112
Device Name CAC Software
Applicant
Imbio, Inc.
1015 Glenwood Ave, Floor 4
Minneapolis,  MN  55405
Applicant Contact Kay Sisavath
Correspondent
Imbio, Inc.
1015 Glenwood Ave, Floor 4
Minneapolis,  MN  55405
Correspondent Contact Lauren Keith
Regulation Number892.1750
Classification Product Code
JAK  
Date Received01/17/2023
Decision Date 06/13/2023
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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