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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K233998
Device Name TRAQinform IQ
Applicant
AIQ Global, Inc.
8000 Excelsior Dr. Ste 400
Madison,  WI  53717
Applicant Contact Dona Alberti
Correspondent
Hogan Lovells US LLP
1735 Market Street
Floor 23
Philadelphia,  PA  19103
Correspondent Contact Kelliann Payne
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/18/2023
Decision Date 09/05/2024
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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