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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 K173444
Device Name Quantitative Total Extensible Imaging (QTxI)
Applicant
AIQ Solutions, Inc.
8025 Excelsior Drive
Madison,  WI  53717
Applicant Contact Dona Alberti
Correspondent
EpiReg LLC
3428 John Muir Drive
Middleton,  WI  53562
Correspondent Contact Mitch Lewandowski
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/06/2017
Decision Date 07/23/2018
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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