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510(k) Data Aggregation
K Number
K072532Device Name
TRUEPIX LCD MEDICAL DISPLAY MONITOR, MODELS TX-5M, TX-3M, TX-2M
Manufacturer
Date Cleared
2007-11-02
(56 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
DOOYANG SYSTEMS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Monochrome LCD Monitors (TX-5M, TX-3M, TX-2M) intended to be used in various kinds of medical image application for which the device complies with the performance specified by the manufacturer of the system. These monitors are not intended for use in mammography.
Device Description
Monochrome LCD Monitors(TX-5M, TX-3M, TX-2M) are used to display images such as Xray, MRI images. These models have resolutions of: 2560x2048, 2048x1536, 1600x1200. These models have USB functions and an optional photo sensor GFU12-SEQ01 made by SEQUEL IMAGING INC. These models are cortified to the EN60601-1 medical safety standard. The monitors use universal Power Supply compatible with AC100V~240V, 50/60Hz. The graphics card needed for the personal computer is the Real Vision & Matrox Scries. The monitors may be deployed in the portrait or the landscape position.
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