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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 K173821
Device Name LungQ Software
Thirona Corporation
Toernooiveld 300
Nijmegen,  NL 6525 EC
Applicant Contact Eva van Rikxoort
Thirona Corporation
Toernooiveld 300
Nijmegen,  NL 6525 EC
Correspondent Contact Jean-Paul Charbonnier
Regulation Number892.1750
Classification Product Code
Date Received12/18/2017
Decision Date 06/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No