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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
Applicant
Thirona Corporation
Toernooiveld 300
Toernooiveld 300,  NL 6525 EC
Applicant Contact Eva van Rikxoort
Correspondent
Thirona Corporation
Toernooiveld 300
Toernooiveld 300,  NL 6525 EC
Correspondent Contact Jean-Paul Charbonnier
Regulation Number892.1750
Classification Product Code
JAK  
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
Predetermined Change
Control Plan Authorized		 No
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