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510(k) Data Aggregation

    K Number
    K251209
    Device Name
    Medical Monitor (32HS710S)
    Manufacturer
    LG Electronics Inc.
    Date Cleared
    2025-06-12

    (55 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    LG Electronics Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This medical monitor is intended to provide color video displays and images from medical equipment which include laparoscopy and endoscopy systems for surgery and various medical imaging systems.
    Device Description
    32HS710S LCD monitor is intended to provide color video displays of images from surgical endoscope, laparoscopic camera system and other compatible medical imaging systems. This Medical Monitor has multiple video interface ports such as Display port, HDMI, DVI and SDI. This monitor displays color video and images from medical equipment which include various medical imaging systems. This monitor can be covered over 100% of the sRGB spectrum.
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    K Number
    K243439
    Device Name
    Medical Monitor (27HS714S)
    Manufacturer
    LG Electronics Inc.
    Date Cleared
    2025-01-28

    (83 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    LG Electronics Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This medical monitor is intended to provide color video displays and images from medical equipment which include laparoscopy and endoscopy systems for surgery and various medical imaging systems.
    Device Description
    27HS714S LCD monitor is intended to provide color video displays of images from surgical endoscope, laparoscopic camera system and other compatible medical imaging systems. This Medical Monitor has multiple video interface ports such as Display port, HDM, DVI and SDI. This monitor displays color video and images from medical equipment which include various medical imaging systems. This monitor can be covered over 99% of the sRGB spectrum.
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    K Number
    K241402
    Device Name
    Medical Monitor (32HR734S)
    Manufacturer
    LG Electronics Inc.
    Date Cleared
    2024-08-12

    (87 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    LG Electronics Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This medical monitor is intended to provide color video displays and images from medical equipment which include laparoscopy and endoscopy systems for surgery and various medical imaging systems.
    Device Description
    32HR734S LCD monitor is intended to provide color video displays of images from surgical endoscope, laparoscopic camera system and other compatible medical imaging systems. This Medical Monitor has multiple video interface ports such as DP, HDMI, DVI, SDI input. This monitor displays color video and images from medical equipment which include various medical imaging systems. This monitor can be covered over 100% of the sRGB spectrum.
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    K Number
    K233599
    Device Name
    X-Clever (ASHK100G)
    Manufacturer
    LG Electronics Inc.
    Date Cleared
    2024-03-18

    (130 days)

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

    LG Electronics Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Software used in a device that saves, enlarges, reduces, views as well as analyzes, transfers and prints medical images. (excluding fluoroscopic, angiographic, and mammographic applications.)
    Device Description
    LG Acquisition Workstation Software ASHK100G is a diagnostic software for final postprocessed X-ray images of body parts of actual patients acquired through the integration of digital X-ray detectors (DXD+ASHK100G; refer to below list for the compatible LG DXD series) and X-ray generators. By integrating the [MWL] and the [PACS] server, this software can be used to check the information and images of the patients' body parts in real time in an HIS (Hospital Information System) based environment.
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    K Number
    K240130
    Device Name
    Medical Monitor (21HQ613D)
    Manufacturer
    LG Electronics Inc.
    Date Cleared
    2024-02-15

    (29 days)

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

    LG Electronics Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
    Device Description
    The Medical 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
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    K Number
    K232985
    Device Name
    24HR513C
    Manufacturer
    LG Electronics Inc.
    Date Cleared
    2023-12-11

    (80 days)

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

    LG Electronics Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Medical Monitor is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
    Device Description
    The Medical 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.
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    K Number
    K232127
    Device Name
    21HQ513D, 32HL512D, 31HN713D, 32HQ713D
    Manufacturer
    LG Electronics Inc.
    Date Cleared
    2023-08-15

    (29 days)

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

    LG Electronics Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    21HQ513D, 32HL512D: This Medical Monitor is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography. 31HN713D, 32HO713D: This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
    Device Description
    The Medical 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.
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    K Number
    K230845
    Device Name
    32HL512D, 31HN713D, 32HQ713D
    Manufacturer
    LG Electronics Inc.
    Date Cleared
    2023-04-27

    (30 days)

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

    LG Electronics Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    32HL512D: This Medical Monitor is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography. 31HN713D, 32HQ713D: This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
    Device Description
    The Medical 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.
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    K Number
    K223423
    Device Name
    32HQ713D
    Manufacturer
    LG Electronics Inc.
    Date Cleared
    2023-03-01

    (107 days)

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

    LG Electronics Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, and diagnosis by trained medical practitioners.
    Device Description
    The Medical 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
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    K Number
    K223546
    Device Name
    14HQ721G-B
    Manufacturer
    LG Electronics Inc.
    Date Cleared
    2023-01-27

    (63 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    LG Electronics Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flat Panel Digital X-ray Detector 14HQ721G-B is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
    Device Description
    This model is an x-ray imaging device, a system that can acquire and process X-ray images as digital images. It utilizes amorphous silicon and a high-performance scintillator to ensure sharp highdefinition image quality with the resolution of 3.6 lp/mm and the pixel pitches of 140 um. This device is a flat panel based X-ray image acquisition device. This device must be used in conjunction with an operating PC and an X-ray qenerator. This device can be used for digitizing and transferring X-ray images for radiological diagnosis. The data transmission between the Detector and PC can be enabled with a wired (cable) or wireless connection. This device does not have a dynamic exposure feature.
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