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Found 20 results
510(k) Data Aggregation
K Number
K222719Device Name
CX50N
Manufacturer
WIDE Corporation
Date Cleared
2023-05-09
(243 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
WIDE Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CX50N LCD Monitor 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 and digital breast tomosynthesis applications.
Device Description
CX50N LCD Monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images.
EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.
CX50N is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.
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K Number
K222716Device Name
MX50N
Manufacturer
WIDE Corporation
Date Cleared
2023-05-08
(242 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
WIDE Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MX50N LCD Monitor System is intended to be used in displaying digital medical images for review and analysis by trained medical practitioners. It is specifical mammography applications and digital breast tomosynthesis applications.
Device Description
MX50N LCD Monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images.
EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.
MX50N is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.
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K Number
K222717Device Name
CL24N
Manufacturer
WIDE Corporation
Date Cleared
2022-10-31
(53 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
WIDE Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CL24N LCD Monitor System is intended to be used in displaying digital medical images for review by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Device Description
CL24N is intended to display high resolution color and gravscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying and reviewing of medical images.
EzCal is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.
EzCal is packed with the display.
While using the CL24N product, use the EzCal S/W provided as a bundle to periodically check whether the product meets the intended use.
If the product does not meet the intended use, the product must be returned to the manufacturer or an authorized service center to be calibrated to a product that can be used normally.
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K Number
K222722Device Name
CW60N
Manufacturer
WIDE Corporation
Date Cleared
2022-10-31
(53 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
WIDE Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CW60N LCD Monitor is intended to be used in displaying digital medical images for review by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Device Description
CW60N LCD Monitor is intended to display high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying and reviewing of medical images.
EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.
EzCal is packed with the display.
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K Number
K210493Device Name
CX30N (CX30PQX)
Manufacturer
Wide Corporation
Date Cleared
2021-04-14
(54 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Wide Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CX30N(CX30PQX) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. The display is not intended for mammography.
Device Description
CX30N(CX30PQX) is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images.
EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.
CX30N(CX30PQX) is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.
CX30N is basic model and CX30PQX is identical to CX30N, except model name.
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K Number
K210491Device Name
CW120N
Manufacturer
Wide Corporation
Date Cleared
2021-04-08
(48 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Wide Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CW120N LCD Monitor System is intended to be used in displaying digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and digital breast tomosynthesis applications.
Device Description
CW120N LCD Monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images.
EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.
CW120N is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.
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K Number
K170781Device Name
MX50N(MX50YQS)
Manufacturer
WIDE Corporation
Date Cleared
2017-04-04
(20 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
WIDE Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MX50N(MX50YQS) LCD Monitor 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 and digital breast tomosynthesis applications.
Device Description
MX50N(MX50YQS) is a flat panel hi-resolution LCD monitor system for displaying digital 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 image display. The WIDE controller board is installed into the PACS workstation computer or other computer system to display PACS medical images.
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K Number
K170783Device Name
CX50N(CX50YQS)
Manufacturer
WIDE Corporation
Date Cleared
2017-03-31
(16 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
WIDE Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CX50N(CX50YQS) LCD Monitor 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 and digital breast tomosynthesis applications.
Device Description
CX50N(CX50YQS) is a flat panel hi-resolution LCD monitor system for displaying digital 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 color image display. The WIDE controller board is installed into the PACS workstation computer system to display PACS medical images.
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K Number
K160354Device Name
MX50T(MX50TQS)
Manufacturer
WIDE CORPORATION
Date Cleared
2016-05-02
(84 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
WIDE CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MX50TQS) LCD Monitor 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 and breast tomosynthesis applications.
Device Description
MX50T(MX50TQS) is a flat panel hi-resolution LCD monitor system for displaying digital 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 image display. The WIDE controller board is installed into the PACS workstation computer or other computer system to display PACS medical images.
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K Number
K160353Device Name
MX50N(MX50YQS)
Manufacturer
WIDE Corporation
Date Cleared
2016-04-22
(74 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
WIDE Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MX50N(MX50YQS) LCD Monitor 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
MX50N(MX50YQS) is a flat panel hi-resolution LCD monitor system for displaying digital 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 image display. The WIDE controller board is installed into the PACS workstation computer or other computer system to display PACS medical images.
Ask a Question
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