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510(k) Data Aggregation

    K Number
    K191137
    Device Name
    5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500
    Manufacturer
    JVC Kenwood Corporation
    Date Cleared
    2019-07-02

    (64 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    JVC Kenwood Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CL-S500 and MS-S500 are intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
    Device Description
    CL-S500 : 21.3 inch Color LCD Monitor 2048 x 2560 (landscape), 2560 x 2048 (portrait) High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display. Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable. Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor. It minimizes luminance unevenness and color unevenness by Uniformity Correction Function to achieve the uniformity of luminance and color on the whole screen. Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC quideline is conducted MS-S500 : 21.3 inch Monochrome LCD Monitor 2048 x 2560 (landscape), 2560 x 2048 (portrait) High-luminance monochrome LCD panel, which has wide view angle, is used for this product. It is designed for medical image display. Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable. Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor. It minimizes luminance unevenness by Uniformity Correction Function to achieve the uniformity of luminance on the whole screen. Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC guideline is conducted.
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    K Number
    K182539
    Device Name
    2MP Color LCD Monitor CL-R211
    Manufacturer
    JVC Kenwood Corporation
    Date Cleared
    2018-10-03

    (19 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    JVC Kenwood Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CL-R211 (CL-R211xxxxx) is intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
    Device Description
    2MP Color LCD Monitor CL-R211. Resolution: 1600 x 1200 (landscape), 1200 x 1600 (portrait). DVI (digital interface) and DisplayPort (digital interface).
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    K Number
    K173434
    Device Name
    2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300
    Manufacturer
    JVC KENWOOD Corporation
    Date Cleared
    2017-12-14

    (42 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    JVC KENWOOD Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CL-S200 (CL-S200xxxxx) and CL-S300 (CL-S300xxxxx) are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
    Device Description
    CL-S200 : 1600 x 1200 (landscape), 1200 x 1600 (portrait) CL-S300 : 2048 x 1536 (landscape), 1536 x 2048 (portrait) DVI (digital interface) and DisplayPort (digital interface)
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    K Number
    K161895
    Device Name
    2MP Color LCD Monitor CCL214 (CL21214)
    Manufacturer
    JVC KENWOOD Corporation
    Date Cleared
    2016-09-08

    (59 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    JVC KENWOOD Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    2MP Color LCD Monitor CCL214 (CL21214) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.
    Device Description
    CCL214 (CL21214) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1600 x 1200 (landscape), 1200 x 1600 (portrait) supporting DVI-D (digital interface) and DisplayPort (digital interface).
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    K Number
    K160326
    Device Name
    5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)
    Manufacturer
    JVC KENWOOD Corporation
    Date Cleared
    2016-02-23

    (18 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    JVC KENWOOD Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) and 5MP Color LCD Monitor CCL550i2 (CL21550) are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. They are to be used in digital mammography PACS, modalities including FFDM, and breast tomosynthensis
    Device Description
    MS55i2 (ML21055, MD211G5) is a 21.3 inch (54 cm) monochrome LCD monitor and CCL550i2 (CL21550) is a 21.3 inch (54 cm) color LCD monitor. Their displays' resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface) and DisplayPort.
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    K Number
    K151134
    Device Name
    21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)
    Manufacturer
    JVC KENWOOD CORPORATION
    Date Cleared
    2015-05-27

    (28 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    JVC KENWOOD CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210) is intended to be used in displaying medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.
    Device Description
    CCL210 (CL21210) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1600 x 1200 (landscape), 1200 x 1600 (portrait) supporting DVI-I (both digital and analog interface) and DisplayPort (digital interface).
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    K Number
    K151007
    Device Name
    21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)
    Manufacturer
    JVC KENWOOD CORPORATION
    Date Cleared
    2015-05-08

    (23 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    JVC KENWOOD CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    21.3 inch (54 cm) inch Color Digital Mammography 5M pixel LCD Monitor CCL550i2 (CL21550) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.
    Device Description
    CCL550i2 (CL21550) is a 21.3 inch (54 cm) color LCD monitor whose display resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface) and DisplayPort.
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    K Number
    K143076
    Device Name
    20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205)
    Manufacturer
    JVC KENWOOD CORPORATION
    Date Cleared
    2014-11-12

    (16 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    JVC KENWOOD CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    20.1 inch (51 cm) Monochrome 2M pixel LCD Monitor ME205 (ML20205) is intended to be used in displaying and viewing medical images for diagnosis by trained Medical practitioners. It is not meant to be used in digital mammography.
    Device Description
    ME205 (ML20205) is a 20.1-inch (51 cm) Monochrome LCD monitor whose display resolution is 1600 x 1200 (landscape), 1200 x 1600 (portrait) supporting DVI-I (both digital and analog interface) and DisplayPort (digital interface).
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    K Number
    K142536
    Device Name
    21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)
    Manufacturer
    JVC KENWOOD CORPORATION
    Date Cleared
    2014-10-03

    (24 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    JVC KENWOOD CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    21.5 inch (54.5 cm) Color 2M pixel LCD Monitor CCL220 (CL2220) is intended to be used in displaying and viewing medical images from PACS, endoscope and ultrasonograph for diagnosis by trained Medical practitioners. It is not meant to be used in digital mammography.
    Device Description
    CCL220 (CL22220) is a 21.5-inch (54.5 cm) Color LCD monitor whose display resolution is 1920 x 1080 (landscape), 1080 x 1920 (portrait) supporting multiple interfaces such as HDMI, BNC, S-video and HD-SDI in addition to DVI and D-Sub.
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    K Number
    K142540
    Device Name
    24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)
    Manufacturer
    JVC KENWOOD CORPORATION
    Date Cleared
    2014-10-03

    (24 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    JVC KENWOOD CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    24.1 inch (61.1 cm) Color 2M pixel LCD Monitor CCL244 (CL24244) is intended to be used in displaying and viewing medical images from PACS, endoscope and ultrasonograph for diagnosis by trained Medical practitioners. It is not meant to be used in digital mammography.
    Device Description
    CCL244 (CL24244) is a 24.1-inch (61.1 cm) Color LCD monitor whose display resolution is 1920 x 1200 (landscape), 1200 x 1920 (portrait) supporting multiple interfaces such as HDMI, BNC, S-video and HD-SDI in addition to DVI and D-Sub.
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