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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 K152847
Device Name DIVA ZSP5812CMI with QUBYX PerfectLum bundle
Applicant
Qubyx , Ltd.
80, Rue Marechal Joffre
Nice,  FR 06000
Applicant Contact MARC LEPPLA
Correspondent
Qubyx , Ltd.
80, Rue Marechal Joffre
Nice,  FR 06000
Correspondent Contact MARC LEPPLA
Regulation Number892.2050
Classification Product Code
PGY  
Date Received09/29/2015
Decision Date 11/17/2015
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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