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510(k) Data Aggregation
K Number
K171229Device Name
DELL UP3017 with QUBYX PerfectLum bundle
Manufacturer
Date Cleared
2017-05-26
(29 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Qubyx Software Technologies Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DELL UP3017 with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners.
The DELL UP3017 can be used only in conjunction with QUBYX PerfectLum.
The device can not be used in primary image diagnosis in mammography.
The device can not be used for a life-support system.
The device does not contact with the patient.
The device is intended for prescription use.
Device Description
The DELL UP3017 with QUBYX PerfectLum is a 30" color display for medical viewing. It provides 2560 x 1600 resolution with an adjustable Look Up Table and a 10 bit panel. It is combined with QUBYX PerfectLum and PerfectLum remote management, a userfriendly DICOM calibration and AAPM TG18 verification software suite. The software allows setting the display function to DICOM, displaying test pattern and performing acceptance and constancy tests.
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K Number
K162196Device Name
Dell UP3216Q with QUBYX PerfectLum bundle
Manufacturer
Date Cleared
2016-08-15
(10 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
QUBYX SOFTWARE TECHNOLOGIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DELL UP3216Q with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners.
The DELL UP3216Q can be used only in conjunction with OUBYX PerfectLum.
The device can not be used in primary image diagnosis in mammography.
The device can not be used for a life-support system.
The device does not contact with the patient.
The device is intended for prescription use.
Device Description
The DELL UP3216Q with QUBYX PerfectLum is a 31.5" color display for medical viewing. It provides 3840x2160 resolution with an adjustable Look Up Table and a 10 bit panel. It is combined with QUBYX PerfectLum and PerfectLum remote management, a userfriendly DICOM calibration and AAPM TG18 verification software suite. The software allows setting the display function to DICOM, displaying test pattern and performing acceptance and constancy tests.
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