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510(k) Data Aggregation

    K Number
    K150377
    Device Name
    Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor
    Manufacturer
    SONY ELECTRONICS, INC.
    Date Cleared
    2015-07-29

    (166 days)

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

    SONY ELECTRONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LCD Monitor is intended to provide 4K 2D color video displays of images from endoscopic / laparoscopic camera systems and other compatible medical imaging systems. The LCD Monitor is a wide-screen, high-definition, medical grade monitor for real-time use during minimally invasive surgical procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.
    Device Description
    The Sony LMD-X310S. LMD-X310MD and LMD-X310NB are 31 inches LCD monitors, and LMD-X550S. LMD-X550MD and LMD-X550NB are 55 inches LCD monitors with an advanced display technology, designed for use in medical environments. These monitors provide 4K resolution 2D color video displays of images from a surgical endoscope, laparoscopic camera system, and other compatible medical imaging systems. They are suitable for environments such as operating rooms. surgical centers, clinics, doctor's offices, and similar locations. LMD-X310S、LMD-X310MD and LMD-X310NB are operated by DC power supply and supplied with a dedicated AC adaptor, AC-300MD. LMD-X310MD is SONY brand model, LMD-X310S is a model for a specified customer and LMD-X310NB is for unspecified customers. MD-X550S, LMD-X550MD and LMD-X550NB are operated by AC power supply. LMD-X550MD is SONY brand model, LMD-X550S is a model for a specified customer and LMD-X550NB is for unspecified customers. Key features include: - A Large and 4K Screen - Wide color qamut - Clear and High-contrast View - A.I.M.E.™ (Advanced Image Multiple Enhancer) - Narrow Bezel - Ergonomic Design - User-friendly Control Panel - A Variety of Display Format - Easy to Clean - Installation-friendly Cabling
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    K Number
    K141346
    Device Name
    SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD
    Manufacturer
    SONY ELECTRONICS, INC.
    Date Cleared
    2014-06-26

    (35 days)

    Product Code
    LMC
    Regulation Number
    892.2040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SONY ELECTRONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sony Hybrid Graphic Printers UT-971AD and UP-991AD are compact, medical grode hlack and white printers that can accept both anslog and digital signal inpus. They are designed to be integrated into radiology imaging systems such as mobile c-arm, ultrasound, cardine intintion laboratory and other compaible medical imaging systems and produce hard copy prints of still images captured by these systems for the patient rocord or for referrals.
    Device Description
    The UP-991AD and UP-971AD Hybrid Graphic Printers are compact black and white printers designed for use with both analog and digital radiology imaging systems such as mobile C-arm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems. They provide 325 dpi high resolution hard copies of still images captured by the imaging system that can then be used as reference prints for patient record purposes or referrals. Both the UP-991AD and UP-971AD Hybrid Graphic Printers provide a multi-picture print mode and panoramic print capability. Additionally, the UP-991AD can store images on a connected USB flash drive and print on transparent blue film media, in addition to paper media. Other conveniences offered by the UP-991AD include automatic detection of media type and an integrated media cutter.
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    K Number
    K141454
    Device Name
    SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD
    Manufacturer
    SONY ELECTRONICS, INC.
    Date Cleared
    2014-06-26

    (24 days)

    Product Code
    LMC
    Regulation Number
    892.2040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SONY ELECTRONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printers are compact, medical grade black and white digital printers. The Sony UP-D898MD (Digital) Graphic Printer accepts only digital signal inputs. The Sony UP-X898MD (Hybrid) Graphic Printer can accept both analog and digital signal inputs. Both models are designed to be integrated into digital radiology imaging systems such as mobile c-arm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems and produce hard copy prints of still images captured by these systems for the patient record or for referrals.
    Device Description
    The Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Printers are compact, medical grade black and white printers. The UP-D898MD only accepts digital signal inputs and the UP-X898MD accepts both analog and digital signal inputs. The printers are designed to be integrated into radiology imaging systems such as mobile c-arm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems and produce 325 dpi high resolution hard copy prints of still images captured by these systems for the patient record purposes or referrals. The images cannot be utilized for diagnostic purposes. Additionally, the UP-X898MD (Hybrid) Printer can store images on a connected USB flash drive.
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    K Number
    K120611
    Device Name
    SONY PVM-2551MD OLED MONITOR
    Manufacturer
    SONY ELECTRONICS, INC.
    Date Cleared
    2012-06-28

    (120 days)

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

    SONY ELECTRONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sony PVM-2551MD OLED Monitor is intended to provide color video displays of images from surgical camera systems. The PVM-2551MD is a widescreen, highdefinition monitor for real-time use during minimally invasive surgical procedures including arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), thorascopy, endoscopy (general, gastroenterological and ENT surgery) and general surgery.
    Device Description
    The Sony PVM-2551MD OLED Monitor is a color video monitor and is intended primarily for use in a medical environment for displaying images captured during minimally invasive and general surgical procedures. The monitor features a 24.5inch widescreen OLED panel and Sony's TRIMASTER™ technology, which has been developed to provide accurate color reproduction, precision imaging, and quality picture consistency. The monitor employs full high-definition (HD) performance with 1920 x 1080 pixels, an aspect ratio of 16:9, and a pixel efficiency of 99.99%. OLED (an acronym for Organic Light-Emitting Diode) is a flat-panel screen technology that represents an advance in display technology. It is an emissive technology that generates light from each pixel. The process that is the basis of OLED is electroluminescence. In the Sony PVM-2551MD OLED Monitor, the OLED panel makes use of an organic material, which emits light when an electric current is applied. Being self-emitting, the strength of luminescence can be controlled by the amount of electric current. This results in quick motion picture response, high contrast and wide dynamic range, and rich color reproduction. In addition to digital signals, the Sony PVM-2551MD OLED Monitor accepts analog signals and converts them to digital signals. The Sony PVM-2551MD OLED Monitor is designed with the flexibility to support a variety of formats as standard and also has two built-in option slots to select, expand, and change input/output signals.
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    K Number
    K113203
    Device Name
    SONY LMD-2451MT LCD MONITOR
    Manufacturer
    SONY ELECTRONICS, INC.
    Date Cleared
    2012-02-24

    (116 days)

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

    SONY ELECTRONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sony LMD-2451MT LCD Monitor is intended to provide 3D and 2D color video displays of images from surgical endoscopic/laparoscopic camera systems and other compatible medical imaging systems. The LMD-2451MT is a widescreen, high-definition, medical grade monitor for real-time use during minimally invasive surgical procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.
    Device Description
    The Sony LMD-2451MT LCD Monitor is intended primarily for use in a medical environment for displaying images captured during minimally invasive surgical procedures. The monitor features a 24-inch widescreen LCD display panel and employs full WUXGA high-definition (HD) performance. The LMD-2451MT also features Sony's ChromaTru® technology for accurate and consistent color matching across multiple monitors. The monitor is 2D/3D switchable and, therefore, is compatible with both 2D and 3D camera systems to show color and texture variations in full HD in both 2D and 3D modes. In addition to digital signals, the LMD-2451MT accepts analog signals and converts them to digital signals. The 3D mode of the Sony LMD-2451MT LCD Monitor enables more realistic depth perception and spatial orientation than is available in the 2D mode. A micro-polarizer 3D filter is built into the monitor and lightweight circular polarizer 3D glasses are supplied as accessories. The Sony LMD-2451MT LCD Monitor is designed with the flexibility to support a variety of formats with two built-in option slots to select, expand, and change input/output signals.
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    K Number
    K083522
    Device Name
    SONY UP-DF750 DIGITAL FILM IMAGER
    Manufacturer
    SONY ELECTRONICS, INC.
    Date Cleared
    2009-01-09

    (44 days)

    Product Code
    LMC
    Regulation Number
    892.2040
    Why did this record match?
    Applicant Name (Manufacturer) :

    SONY ELECTRONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sony UP-DF750 Digital Film Imager is a thermal printer intended for use in printing medical diagnostic images from mammography systems. The UP-DF750 is a multi-format imager and also is intended for printing high-resolution diagnostic images from CT, MRI, CR, DR and other compatible medical imaging systems. The Sony UP-DF750 is intended for use by medical radiologists or other appropriately trained medical personnel.
    Device Description
    The Sony UP-DF750 Digital Film Imager is a device for digitally printing black and white still images with DICOM format. The Sony UP-DF750 Digital Film Imager is connected to a DICOM network and the image from a mammography, CT, MRI, CR, DR or other compatible medical imaging system (modality) is transmitted via the DICOM network. Whenever a DICOM file is received, the Sony UP-DF750 Digital Film Imager will understand the DICOM information and images will be formatted in the memory. Then, this information will be transferred to the Print Engine through an internal interface (VF). The data will be processed through sharpness, gamma curve and other types of compensation. The Sony UP-DF750 Digital Film Imager is intended to be used to print DICOM images obtained from a medical modality for the purpose of diagnosis.
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