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510(k) Data Aggregation

    K Number
    K113451
    Device Name
    NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
    Manufacturer
    NIDEK TECHNOLOGIES SRL
    Date Cleared
    2012-05-08

    (169 days)

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

    NIDEK TECHNOLOGIES SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NAVIS-EX is intended to capture, display, store and manipulate images of the retina and the anterior segment of the eye, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.
    Device Description
    The Non-Mydriatic Auto Fundus Camera AFC-330 with Image Filing Software NA VIS-EX ("AFC-330 with NA VIS-EX") is a conventional non-mydriatic auto fundus camera. The AFC-330 with NAVIS-EX captures fundus images using a built-in colour CCD camera without the use of mydriatic agents. With this single device, registration of patient information, image capture, and viewing of captured images are possible. By connecting a personal computer (PC) to the device via a LAN and installing the NA VIS-EX image filing system software, images captured by this device can be transferred to the PC and viewed and managed on the PC.
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    K Number
    K070231
    Device Name
    ORION
    Manufacturer
    NIDEK TECHNOLOGIES SRL
    Date Cleared
    2007-04-24

    (90 days)

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

    NIDEK TECHNOLOGIES SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ORION is an ophthalmic camera that is indicated for use in capturing images of the retina.
    Device Description
    The Nidek Technologies Srl ORION is an instrument for the diagnosis of retinal diseases. It is able to capture color images of the patient retina through CCD cameras. The fundus camera ORION is supplied with Xenon light and IR LEDs sources suitable for performing the above described examinations. The system includes also the dedicated NAVIS software (running with Windows XP e 2000 operative system).
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    K Number
    K061768
    Device Name
    MP-1 MICROPERIMETER
    Manufacturer
    NIDEK TECHNOLOGIES SRL
    Date Cleared
    2006-09-28

    (97 days)

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

    NIDEK TECHNOLOGIES SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MP-1 MICRO PERIMETER is indicated for use as : - Color retinography . - Fixation examiner ● - Fundus-related microperimetry . - Visual rehabilitation. .
    Device Description
    The Nidek Technologies Srl MP-1 MICRO PERIMETER is an instrument for the diagnosis of retinal diseases. It is able to capture infrared live sequences and color images of the patient retina through CCD cameras and at the same time to project light stimuli on the retina in those retinal positions chosen by the operator. The MP-1 MICRO PERIMETER is supplied with Xenon light and Halogen light sources suitable for performing the above described examinations. The system includes also a suitable Insulation transformer, a LCD S-VGA Monitor and an IBM Personal Computer, which incorporates the dedicated NAVIS software (with Windows 2000 operative system).
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    K Number
    K023719
    Device Name
    MP-1 MICRO PERIMETER
    Manufacturer
    NIDEK TECHNOLOGIES SRL
    Date Cleared
    2002-12-23

    (48 days)

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

    NIDEK TECHNOLOGIES SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MP-1 MICRO PERIMETER is indicated for use as : - Color retinography - Fixation examiner - Fundus-related microperimetry
    Device Description
    The Nidek Technologies Srl MP-1 MICRO PERIMETER is an instrument for the diagnosis of retinal diseases. It is able to capture infrared live sequences and color images of the patient retina through CCD cameras and at the same time to project light stimuli on the retinal positions chosen by the operator. The MP-1 MICRO PERIMETER is supplied with Xenon light and Halogen light sources suitable for performing the above described examinations. The system includes also a suitable Insulation transformer, a 15-inch LCD S-VGA Monitor and an IBM Personal Computer, which incorporates the dedicated NAVIS software (with Windows 2000 operative system).
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    K Number
    K012416
    Device Name
    CONFOSCAN 2 CONFOCAL MICROSCOPE
    Manufacturer
    NIDEK TECHNOLOGIES SRL
    Date Cleared
    2001-10-26

    (88 days)

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

    NIDEK TECHNOLOGIES SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ConfoScan 2 Confocal Microscope is intended for use in the precise display and digital storage of images of the corneal layers (endothelium, descemet's membrane, stroma, bowman's membrane, and epithelium) and corneal components (endothelial cells, stromal keratocytes, nerve fibers, basalar and superficial cells). The microscope is also used for optical pachymetry, post-surgery interface evaluation, endothelial cell analysis, haze detection, foreign bodies, corneal dystrophies, keratoconus, keratitis, and trauma. The ConfoScan 2 Confocal Microscope is indicated for use as a diagnostic tool for observation of the cell layers of the anterior parts of the eye.
    Device Description
    The Nidek Technologies Srl ConfoScan 2 Confocal Microscope is a fully digital, corneal confocal microscope that allows a user to view and image human corneal layers in vivo. The confocal arrangement consists of one slit that illuminates the tissue and a second slit that filters the reflected light from unfocused layers. The user can view, magnify, measure, and photograph scparate layers of the transparent structures and tissues of the cornea. One examination records 350 different images. The ConfoScan 2 microscope is supplied with a Quartz Halogen light source and a scauning slit, suitable for performing ophthalmic examination. The system includes a 15-inch LCD S-VGA Monitor and a Personal Computer, which incorporates the dedicated NAVIS software.
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