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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 K171229
Device Name DELL UP3017 with QUBYX PerfectLum bundle
Applicant
Qubyx Software Technologies Inc.
501 Silverside Road, Suite 105
Wilmington,  DE  19809
Applicant Contact Marc Leppla
Correspondent
Qubyx Software Technologies Inc.
501 Silverside Road, Suite 105
Wilmington,  DE  19809
Correspondent Contact Marc Leppla
Regulation Number892.2050
Classification Product Code
PGY  
Date Received04/27/2017
Decision Date 05/26/2017
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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