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510(k) Data Aggregation

    K Number
    K241105
    Device Name
    3MP Color LCD Monitor (CL-S301)
    Manufacturer
    Jvckenwood Corporation
    Date Cleared
    2024-08-01

    (101 days)

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

    Jvckenwood Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CL-S301 is 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
    21.3 inch Color LCD Monitor 1536 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. Luminance and the color mura correction functions will help achieve uniformity on the whole screen.
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    K Number
    K222864
    Device Name
    8MP Color LCD Monitor CL-R813
    Manufacturer
    JVCKENWOOD Corporation
    Date Cleared
    2022-12-21

    (90 days)

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

    JVCKENWOOD Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CL-R813 is 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
    32-inch 8MP Color LCD Monitor CL-R813, 3840 x 2160 (landscape) - 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. - Luminance mura correction functions will help achieve uniformity on the whole screen.
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    K Number
    K212985
    Device Name
    6MP Color LCD Monitor CL-S600
    Manufacturer
    JVCKENWOOD Corporation
    Date Cleared
    2021-12-16

    (90 days)

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

    JVCKENWOOD Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CL-S600 is intended to be used in displaying and viewing medical images for trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
    Device Description
    30 inch Color LCD Monitor 3280 x 2080 (landscape) 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. Luminance and the color mura correction functions will help achieve uniformity on the whole screen.
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    K Number
    K203733
    Device Name
    12MP Color Digital Mammography LCD Monitor CL-S1200
    Manufacturer
    JVCKENWOOD Corporation
    Date Cleared
    2021-06-29

    (190 days)

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

    JVCKENWOOD Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CL-S1200 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
    Device Description
    30.9 inch Color Digital Mammography LCD Monitor 4200 x 2800 (landscape) High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display including mammography. 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. Luminance and the color mura correction functions will help achieve uniformity on the whole screen. A glass filter protects the surface of the LCD panel.
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    K Number
    K210345
    Device Name
    2MP Monochrome LCD Monitor MS-S200
    Manufacturer
    Jvckenwood Corporation
    Date Cleared
    2021-04-23

    (77 days)

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

    Jvckenwood Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MS-S200 is 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
    21.3 inch (54cm) Monochrome LCD Monitor 1600 x1200 (landscape) 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
    K200161
    Device Name
    3MP Monochrome Digital Mammography LCD Monitor MS-S300
    Manufacturer
    Jvckenwood Corporation
    Date Cleared
    2020-02-21

    (30 days)

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

    Jvckenwood Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MS-S300 is intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel. It's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
    Device Description
    21.3 inch Monochrome Digital Mammography LCD Monitor 2048 x 1536 (landscape), 1536 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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