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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 K232412
Device Name LungQ v3.0.0
Applicant
Thirona BV
Toernooiveld 300
Toernooiveld 300,  NL 6525 EC
Applicant Contact Eva Van Rikxoort
Correspondent
Thirona BV
Toernooiveld 300
Toernooiveld 300,  NL 6525 EC
Correspondent Contact Eva Van Rikxoort
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/10/2023
Decision Date 01/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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