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510(k) Data Aggregation
K Number
K081109Device Name
CORONIS 5MP MAMMO SL, MODEL MDMG 6121
Manufacturer
BARCOVIEW, MEDICAL IMAGING SYSTEMS
Date Cleared
2008-05-02
(14 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
BARCOVIEW, MEDICAL IMAGING SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Coronis 5MP Mammo SL (MDMG 6121) Display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
Device Description
Not Found
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K Number
K073007Device Name
CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL
Manufacturer
BARCOVIEW, MEDICAL IMAGING SYSTEMS
Date Cleared
2008-02-14
(113 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
BARCOVIEW, MEDICAL IMAGING SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K072875Device Name
NIO 5MP DISPLAY, MODEL E5620
Manufacturer
BARCOVIEW, MEDICAL IMAGING SYSTEMS
Date Cleared
2008-01-22
(105 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
BARCOVIEW, MEDICAL IMAGING SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K073205Device Name
NIO 5MP, MODEL MDNG-5121
Manufacturer
BARCOVIEW, MEDICAL IMAGING SYSTEMS
Date Cleared
2007-12-19
(36 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
BARCOVIEW, MEDICAL IMAGING SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K070726Device Name
NIO COLOR 3MP AND MDNC 3120
Manufacturer
BARCOVIEW, MEDICAL IMAGING SYSTEMS
Date Cleared
2007-05-02
(48 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
BARCOVIEW, MEDICAL IMAGING SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MDNC 3120 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The MDNC 3120, which is part of the Nio Color 3MP system, will be marketed separately.
The Nio Color 3MP is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The Nio Color 3MP, containing the display MDNC 3120, the software MediCal QAWeb Agent and a graphic board, will be marketed as separate device.
Device Description
MDNC 3120 is a 20.8" color LCD display for medical viewing. It is combined with MediCal QAWeb Agent, a user-friendly software that allows to optimize the display for DICOM-compliant viewing.
Nio Color 3MP is a display system for medical viewing. It consists of 3 components: MDNC 3120 is a 20.8" color LCD display. MediCal QAWeb Agent is a softcopy QA software application for local calibration and QA control. The system also contains a fast high-resolution display controller board that plugs into a PACS workstation computer. Standard the system is delivered with the MXRT 2100 board, but the user can opt for another type of display controller board (MXRT 5100 or MXRT 7100). The display system can be a single-head system or multi-head system. In the last case it contains multiple displays and display controller boards.
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