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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
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