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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 K192531
Device Name QyScore Software
Applicant
Qynapse
67 rue Saint Jacques
Paris,  FR 75005
Applicant Contact Olivier Courreges
Correspondent
Daniel & Daniel Consulting, LLC
340 Jones Lane
Gardnerville,  NV  89460
Correspondent Contact Michael Daniel
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/16/2019
Decision Date 12/13/2019
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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