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510(k) Data Aggregation

    K Number
    K141325
    Device Name
    TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA
    Manufacturer
    TOPCON CORP.
    Date Cleared
    2014-10-23

    (156 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOPCON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Non-Mydriatic Retinal Camera TRC-NW8F plus is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eye care professional, with the use of a mydriatic or without the use of a mydriatic.
    Device Description
    The Topcon TRC-NW8F plus is a fundus camera designed to observe, photograph and record the fundus oculi of a patient's eye with or without the use of a mydriatic. The TRC-NW8F plus does not come into contact with the patient's eye and provides the fundus oculi image information as an electronic image for later analysis. The TRC-NW8F plus performs color photography, fluorescein fundus angiography and Autofluorescence (FAF) photography. This product is equipped with an observation monitor used for observation purposes and display of a photographed images. The TRC-NW8F plus uses an attached commercial digital single-lens reflex camera to photograph or record the fundus oculi of a patient. A built in digital camera is used for taking autofluorescence images. The TRC-NW8F plus is only to be used with the Nikon D7000 digital camera. A photographed image may be recorded on a commercial memory card built into a commercial digital single-lens reflex camera, a personal computer or commercial memory device (flash memories, hard disc, etc.). A commercial digital printer is connected and can print the observed images and the photographed images of the fundus.
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    K Number
    K133667
    Device Name
    SLIT LAMP SL-D701
    Manufacturer
    TOPCON CORP.
    Date Cleared
    2014-08-26

    (270 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOPCON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Slit Lamp SL-D701 is an AC-powered slittlamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
    Device Description
    The Slit Lamp SL-D701 is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light. The Slit Lamp SL-D701 is composed of the following components: microscope unit, illumination unit, base unit, chinrest, table and power unit. The slitlamp biomicroscope is used for the observation of the eye. It has an illumination unit to illuminate the eye, and a binocular stereoscopic microscope to zoom and observe patient's eyes, and also can observe the three-dimensional image.
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    K Number
    K130289
    Device Name
    TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
    Manufacturer
    TOPCON CORP.
    Date Cleared
    2013-05-10

    (94 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOPCON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TRC-NW8 is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eye care professional, with the use of a mydriatic or without the use of a mydriatic.
    Device Description
    This product is a retinal camera designed to observe, photograph or record the fundus oculi of a patient without coming into contact with the patient's eye and provide as an electronic image the obtained fundus oculi information for subsequent diagnosis. The TRC-NW8 can take both color photography and red-free photography. The TRC-NW8 is equipped with an observation monitor used for observation purpose and display of a photographed image. This product uses attached commercial digital single-lens reflex camera to photograph or record the fundus oculi of a patient. A photographed image may be recorded on a commercial memory card built into a commercial digital single-lens reflex camera or a personal computer (hereinafter referred to as a PC) or commercial memory devices (flash memories, hard disc, etc.). A commercial digital printer is connected and can print the observed images and the photographed images of the fundus.
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    K Number
    K100207
    Device Name
    NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
    Manufacturer
    TOPCON CORP.
    Date Cleared
    2010-02-12

    (18 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOPCON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NON-MYDRIATIC RETINAL CAMERA TRC-NW8F is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eye care professional, with the use of a mydriatic or without use of a mydriatic.
    Device Description
    This product is a retinal camera designed to observe, photograph or record the fundus oculi of a patient without coming into contact with the patient's eye and provide as an electronic image the obtained fundus oculi information for subsequent diagnosis. This product can take both color photography and fluorescein angiography. This product is equipped with an observation monitor used for observation purpose and display of a photographed image. This product uses attached commercial digital single-lens reflex camera to photograph or record the fundus oculi of a patient. A photographed image may be recorded on a commercial memory card built into an commercial digital single-lens reflex camera or a personal computer (hereinafter referred to as a PC) or commercial memory devices (flash memories, hard disc, etc.). A commercial digital printer is connected and can print the observed images and the photographed images of the fundus.
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    K Number
    K092470
    Device Name
    OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000
    Manufacturer
    TOPCON CORP.
    Date Cleared
    2009-09-02

    (21 days)

    Product Code
    OBO
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOPCON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in vivo viewing, axial, cross-sectional and three-dimensional imaging and measurement of posterior ocular structures including retina, retinal nerve fiber layer, macula, and optic disk. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior segment of the eye.
    Device Description
    The 3D OCT-2000 is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging of the retina, retinal nerve fiber layer and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to macular edema and central serous retinopathy. During OCT imaging, the scan beam for the 3D OCT-2000 is delivered as pulsed lighting. The PC software of the 3D OCT-2000 has same functions of the PC software of the 3D OCT-1000 and 3D OCT-10000 MARK II and also the PC software of the 3D OCT-2000 has same functions for the measurement of retinal thickness of the 3D OCT-1000 for Measurement of Retinal Thickness.
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    K Number
    K090115
    Device Name
    RETINA CAMERA TRC-NW7SF MARK II
    Manufacturer
    TOPCON CORP.
    Date Cleared
    2009-06-30

    (160 days)

    Product Code
    HKI, TOP
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOPCON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TOPCON Retinal Camera TRC-NW7SF MARK II is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eye care professional, with the use of a mydriatic or without use of a mydriatic. Retina Camera TRC-NW7SF MARK II system is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eye care professional, with or without the use of mydriatic.
    Device Description
    This product is a retinal camera designed to observe, photograph or record the fundus oculi of a patient without coming into contact with the patient's eye and provide as an electronic image the obtained fundus oculi information for subsequent diagnosis. This product comes in two types: a type that capable of both color photography and fluorescein angiography (hereinafter referred to as FA photography); and "Type IA" capable of color photography, FA photography and indocyanine green angiography (hereinafter referred to as IA photography). This product is either equipped with or without an observation monitor used for observation purpose and display of a photographed image. This product comes in three types: a type that houses a digital photography unit for photographing an image; a type to which a commercial TV camera is attached; and a type to which a commercial digital single-lens reflex camera. A digital photography unit, a TV camera and a digital single-lens reflex camera are hereinafter generally referred to as an electronic photography device. A photographed image may be recorded on a commercial memory card built into an electronic photography device, or a connected commercial printer, or a personal computer (hereinafter referred to as a PC).
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    K Number
    K082364
    Device Name
    IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR
    Manufacturer
    TOPCON CORP.
    Date Cleared
    2008-09-30

    (43 days)

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

    TOPCON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMAGEnet Professional PC Software System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from computerized diagnostic imaging devices through direct connection with the instruments or through computerized networks. The software system is indicated for use with retinal camera or digital camera imaging devices, including retinal cameras, non-mydriatic retinal cameras, and slit lamps.
    Device Description
    The IMAGEnet Professional PC Software System is a computerized software system that collects, stores, and manages digital images of the retina and anterior segment of the eye. The IMAGEnet Professional PC Software System is compatible with retinal camera or digital camera imaging devices, including retinal cameras, non-mydriatic retinal cameras, and slit lamps. The IMAGEnet Professional PC Software System is installed in a Windows 2000 or Windows XP Compatible PC to automate the functions of image capture, database archival of images, and image processing. The software includes optional functions that allow the user to stitch multiple images together or estimate the desired laser treatment size for photodynamic therapy (PDT). The Topcon IMAGEnet Professional PC Software System is intended as a software program for the use in the management of digital images acquired from diagnostic instruments that capture images of the retina and anterior segment of the eye.
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    K Number
    K063388
    Device Name
    TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM
    Manufacturer
    TOPCON CORP.
    Date Cleared
    2007-06-22

    (226 days)

    Product Code
    OBO
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOPCON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Topcon 3D OCT-1000 is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging of the retinal nerve fiber layer and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to macular edema and central serous retinopathy.
    Device Description
    The components of the Topcon 3D OCT-1000 include a Main Unit, which houses three optical systems for observing and photographing the retina, a Power Supply Unit, a chin rest, a Spectroscope, and the ability to connect a personal computer for image viewing and analysis.
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    K Number
    K041367
    Device Name
    TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA
    Manufacturer
    TOPCON CORP.
    Date Cleared
    2004-11-05

    (165 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOPCON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Topcon Model TRC-NW200 Non-Mydriatic Camera is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eyecare professional, without the use of a mydriatic.
    Device Description
    The Topcon TRC-NW200 is a non-mydriatic ophthalmic camera that captures and displays images of the eye. The images are captured by using halogen illumination with an infrared filter for observation and a xenon flash bulb for photography. There is no laser illumination. Alignment dots and focusing bars assist the operator in properly positioning the camera. The operator presses a button on the top of the joystick to capture the image. The image is then displayed on the built-in LCD display or, if desired, transferred to a personal computer.
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