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510(k) Data Aggregation
K Number
K073358Device Name
LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50/MM50A
Manufacturer
Date Cleared
2008-04-25
(148 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HEEYOUNG CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Lumimed Series 5MP Digital Flat Panel Display System ™ is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.
Device Description
Lumimed Series 5MP Digital Flat Panel Display System™ is a flat panel hiresolution LCD monitor system for displaying medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale and color image display. The controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.
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K Number
K073292Device Name
MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM
Manufacturer
Date Cleared
2008-01-18
(56 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HEEYOUNG CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MM/MMA/Color Series Digital Flat Panel Display System™ is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. This device must not be used for primary image diagnosis in mammography
Device Description
The MM/MMA/Color Series Digital Flat Panel Display System™ is a flat panel hiresolution LCD monitor system for displaying medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale and color image display. The controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.
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K Number
K052120Device Name
LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50
Manufacturer
Date Cleared
2005-12-16
(134 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
HEEYOUNG CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Monochrome LCD Monitors intended to be used in various kinds of medical image applications (excluding digital mammography) for which the device complies with the performance specified by the manufacturer of the system.
Device Description
Monochrome LCD Monitors (MM 20, MM 30 and MM 50) are used to display images such as X-ray, or MRI images. These models have resolutions of: 2560 X 2048, 2048 X 1536 and 1600 X 1200. These models have USB functions and an optional photo sensor GFU12-SEQ01 made by Gretagmacbeth. These models are certified to the EN 60601-1 medical safety standard. The monitors use universal switching power supplies compatible with AC100V-120V/200V-240V ,50/60Hz. The graphics card needed for the personal computer is the VREngine MD/SMD Series. The monitors may be deployed in the portrait or the landscape position.
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