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510(k) Data Aggregation

    K Number
    K061674
    Device Name
    RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER
    Date Cleared
    2006-08-23

    (70 days)

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

    TALIA TECHNOLOGY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RTA 5 & RTA Model E Retinal Thickness Analyzer ("RTA 5 & RTA Model E") is a computerized slitlamp biomicroscope that is intended to provide manual and computerized tomography of the retina in vivo. The RTA 5 & RTA Model E scans successive slit images on the fundus, without the need for a contact lens, to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. It is indicated for assessing the area and location of retinal thickness abnormalities, such as thickening due to macular edema and atrophy associated with degenerative diseases, and for visualizing other retinal pathologies.
    Device Description
    The RTA 5 & RTA Model E is a computerized electro-optical system comprised of two primary components, namely the optical head and the computer system. The main elements of the optical head include laser and conventional light sources, optics, a scanner, and a digital camera. The RTA 5 & RTA Model E is a computerized slitlamp biomicroscope that provides manual and computerized tomography of the retina in vivo. The RTA 5 & RTA Model E scans successive slit images of the fundus to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. The RTA 5 & RTA Model E uses a solid-state laser source that emits green light at a wavelength of 532 nm. The beam is focused into a thin slit and, by means of a beam-splitter, is directed toward the eye. The scanner and optics then detect the image of the illuminated portion of the retina and transmit the image to the digital camera. The digital camera then captures the image, where it can then be stored and analyzed by the computer system.
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    K Number
    K041290
    Device Name
    RTA MODEL D RETINAL THICKNESS ANALYZER
    Date Cleared
    2004-05-24

    (11 days)

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

    TALIA TECHNOLOGY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RTA Model D Retinal Thickness Analyzer ("RTA Model D") is a computerized slitlamp biomicroscope that is intended to provide manual and computerized tomography of the retina in vivo. The RTA Model D scans successive slit images on the fundus, without the need for a contact lens, to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. It is indicated for assessing the area and location of retinal thickness abnormalities, such as thickening due to macular edema and atrophy associated with degenerative diseases, and for visualizing other retinal pathologies.
    Device Description
    The RTA Model D is a computerized electro-optical system comprised of two primary components, namely the optical head and the computer system. The main elements of the optical head include laser and conventional light sources, optics, a scanner, and a digital camera. The RTA Model D is a computerized slitlamp biomicroscope that provides manual and computerized tomography of the retina in vivo. The RTA Model D scans successive slit images of the fundus to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. The RTA Model D uses a solid-state laser source that emits green light at a wavelength of 532 nm. The beam is focused into a thin slit and, by means of a mirror, is directed toward the eye. The scanner and optics then detect the image of the illuminated portion of the retina and transmit the image to the digital camera. The digital camera then captures the image, where it can then be stored and analyzed by the computer system.
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    K Number
    K031312
    Device Name
    RTA MODEL D RETINAL THICKNESS ANALYZER
    Date Cleared
    2003-05-06

    (12 days)

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

    TALIA TECHNOLOGY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RTA Model D Retinal Thickness Analyzer ("RTA") is a computerized slitlamp biomicroscope that is intended to provide manual and computerized tomography of the retina in vivo. The RTA scans successive slit images on the fundus, without the need for a contact lens, to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. It is indicated for assessing the area and location of retinal thickness abnormalities, such as thickening due to macular edema and atrophy associated with degenerative diseases, and for visualizing other retinal pathologies.
    Device Description
    The RTA is a modification of the previously cleared CRTA Clinical Retinal Thickness Analyzer ("CRTA"). As with the CRTA, the RTA is a computerized electro-optical system comprised of two primary components, namely the optical head and the computer system. The main elements of the optical head include laser and conventional light sources, optics, a scanner, and a digital camera. The RTA is a computerized slitlamp biomicroscope that provides manual and computerized tomography of the retina in vivo. The RTA scans successive slit images of the fundus to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. The RTA uses a helium neon laser source that emits green light at a wavelength of 543.3 nm. The beam is focused into a thin slit and, by means of a mirror, is directed toward the eye. The scanner and optics then detect the image of the illuminated portion of the retina and transmit the image to the digital camera. The digital camera then captures the image, where it can then be stored and analyzed by the computer system.
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    K Number
    K000731
    Device Name
    MODIFICATION TO RTA RETINAL THICKNESS ANALYZER
    Date Cleared
    2000-03-31

    (25 days)

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

    TALIA TECHNOLOGY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K964137
    Device Name
    RTA RETINAL THICKNESS ANALYZER
    Date Cleared
    1997-02-03

    (111 days)

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

    TALIA TECHNOLOGY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RTA is a computerized laser slitlamp biomicroscope that is intended to provide manual and computerized tomography of the retina in vivo. The RTA scans successive slit images on the fundus, without the need for a contact lens, to determine the thickness and the inner structure of the retina, both by observation of the slit images and by computer analysis of these images. It is indicated for assessing the area and location of retinal thickness abnormalities, such as thickening due to macular edema and atrophy associated with degenerative diseases, and for visualizing other retinal pathologies.
    Device Description
    The Talia RTA is a computerized electro-optical system comprised of two primary components, the optical head and the computer system. The main elements of the optical head include laser and conventional light sources, optics, a scanner, and three digital cameras. The optical head has a 0.2 mW helium neon (HeNe) laser that emits green light at a wavelength of 543.5 nm. The beam is focused into a thin slit, 2.2 mm in length and 15 microns in width. The mirror directs the laser beam toward the eye, but permits simultaneous illumination with the conventional slit. The laser scans 10 slits of 2 mm length in each scan and can scan at a rate of 20 msec per slit for retinas. The stereo angle of the scan (the angle between the laser beam on the retina and the detector axis) can be set at 11.5° or 5.7°. The scan density (the distance between slits in the scan) is 200 microns for normal density and has a total scan area of 2 x 2 mm. The scan density for dense density is 100 microns and has a total scan area of 1 x 2 mm. The computer system consists of the computer, peripheral boards, color monitor, printer, keyboard, mouse, footpedal, isolation transformer, and software. The RTA software is composed of two parts, the control software and the analysis software. The control software controls the operation of the RTA. For analysis of images to create thickness maps, it invokes the analysis software.
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