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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
Gerdnerville,  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
Predetermined Change
Control Plan Authorized		 No
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