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510(k) Data Aggregation
K Number
K160328Device Name
DIVA ZSP2105CMI with QUBYX PerfectLum bundle
Manufacturer
Date Cleared
2016-02-25
(20 days)
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
THE LINDEN GROUP CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DIVA ZSP2105CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, including those of mammography, for review, analysis and diagnosis by trained medical practitioners.
The DIVA ZSP2105CMI can be used only in conjunction with QUBYX PerfectLum.
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 DIVA ZSP2105CMI with QUBYX PerfectLum is a 21.3" monochrome display for medical viewing. It can be used for diagnostic viewing or normal reviewing purpose of medical images like computed tomography images, digitalized x-ray images, etc. It is combined with QUBYX PerfectLum and PerfectLum Remote Management, a user-friendly DICOM calibration and AAPM TG18 verification software suite. The software allows setting the display function to DICOM GSDF, displaying test patterns and performing acceptance and constancy tests according to AAPM TG18.
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