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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 K111385
Device Name DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE
Applicant
Qubyx Limited
80, Rue Marechal Joffre
Nice,  FR 06000
Applicant Contact MARC LEPPLA
Correspondent
Qubyx Limited
80, Rue Marechal Joffre
Nice,  FR 06000
Correspondent Contact MARC LEPPLA
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/17/2011
Decision Date 01/30/2012
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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