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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Diagnostic Radiology
510(k) Number K131601
Device Name DELL U3014 WITH QUBYX PERFECTLUM BUNDLE
Applicant
Qubyx Limited
80, Rue Marechal Joffre
Nice,  FR 06000
Applicant Contact ALICE KOTYLARENKO
Correspondent
Qubyx Limited
80, Rue Marechal Joffre
Nice,  FR 06000
Correspondent Contact ALICE KOTYLARENKO
Regulation Number892.2050
Classification Product Code
PGY  
Date Received06/03/2013
Decision Date 07/07/2014
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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