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510(k) Data Aggregation

    K Number
    K142423
    Device Name
    EyeSuite Imaging
    Manufacturer
    HAAG-STREIT AG
    Date Cleared
    2014-09-10

    (13 days)

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

    HAAG-STREIT AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EyeSuite Imaging is a software program intended for use for controlling digital imaging devices and for acceptance. transfer, display, storage and digital processing of documentational ophthalmic images and videos, acquired from computerized diagnostic instruments, through direct connection or through networks. EyeSuite Basic is a patient and examination management system, acting as a base and communication platform for other EyeSuite software components.
    Device Description
    EyeSuite Imaging is a software used by eye care professionals together with imaging systems on Haaq-Streit slit lamps or other devices. EveSuite Imaging requires a computer running Microsoft Windows in one of the following versions: - Windows XP, SP3 (32 Bit) ● - Windows Vista, SP2 (32 and 64 Bit) . - . Windows 7. SP1 (32 and 64 Bit) - Windows 8 and 8.1 (32 and 64 Bit) . A slit lamp is an instrument consisting of a light source that can be focused to shine a thin sheet of light into the eye. It is used in conjunction with a biomicroscope. The lamp facilitates an examination of the anterior segment, or frontal structures and posterior segment, of the human eye. With an imaging system a two dimensional image or video of what is seen through the biomicroscope can be recorded into widely used data formats, such as TIFF or JPEG in case of still images or MJPEG in case of a video. These records can be used for documentational purpose or to explain findings to the patient. It is optionally possible to connect the software to a DICOM PACS for storing the recorded image data. EyeSuite Imaging allows the user to control the Haag-Streit imaging devices attached to the slit lamp or other devices, enables recording of images or videos, allows to view, modify and store the results together with accompanying information such as patient data, information on camera settings or notes of the examiner. The examiner may also highlight significant image features by using the provided draw and measure tools that allow to add predefined overlays, pixel measurements or angle measurements in the image plane. The software is not able and not intended to provide any diagnosis, but it helps the user to examine the visible structures of the eye and enables him to present and store his findings. EyeSuite Imaging is a software application which is part of the Haag-Streit EyeSuite software product family that is licensed to customers of Haag-Streit Imaging devices. All imaging data acquisition, processing or consistency-check related features are provided by the EyeSuite Imaging Extension component and the EyeSuite Imaging Viewer component. Standard elements such as user management, patient management. database connections, basic settings, installation and backup routines are provided by the EyeSuite Basic component. The architectural decision of isolating standard features into the EyeSuite Basic component was made to reuse these features in other EyeSuite software products. The imaging modules supported by EyeSuite Imaging are the Haag-Streit IM900 and the Haag-Streit CM900. The EyeSuite Imaging software allows to take control of camera features such as exposure time, camera gain or white balance settings. The release modules supported by EyeSuite Imaging are the Haag-Streit RM01, the Haag-Streit RMX01 and the Haag-Streit Footswitch. These supplementary devices are registered accessory parts to the class II slit lamp microscope (FDA clearance number K100202),
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    K Number
    K100202
    Device Name
    SLIT LAMP BO 900, BQ 900, BP900
    Manufacturer
    HAAG-STREIT AG
    Date Cleared
    2010-03-19

    (53 days)

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

    HAAG-STREIT AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An AC-powered slitlamp biomicroscope is 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
    An AC-powered Slitlamp Biomicroscope 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 illumination is composed of the light source, the slit; collimation and imaging optics, and infrared and ultraviolet filters and a dielectric mirror. The slit lamps have the option to combine a background illumination together with the slit illumination.
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    K Number
    K082891
    Device Name
    LENSTAR, MODEL LS900
    Manufacturer
    HAAG-STREIT AG
    Date Cleared
    2009-10-20

    (385 days)

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

    HAAG-STREIT AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LENSTAR LS 900 is a non-invasive, non-contact OLCR (Optical Low Coherence Reflectometry) Biometer used for obtaining ocular measurements and performing calculations to assist in the determination of the appropriate power and type of IOL (intraocular lens) for implantation after removal of the natural crystalline lens following cataract removal. The LENSTAR LS 900 measures: - Axial eye length - Corneal thickness - Anterior chamber depth - Aqueous depth - Lens thickness - Radii of curvature of flat and steep meridian - Axis of the flat meridian - White to white distance - Pupil diameter
    Device Description
    The LENSTAR LS 900 is a non-invasive, non-contact system for measuring the parameters of the human eye required to determine the appropriate IOL for implantation and to calculate the optimal power of the IOL. The LENSTAR LS 900 measures: axial eye length, corneal thickness, anterior chamber depth, lens thickness, radii of curvature of flat and steep meridian, axis of flat or step meridian, white to white distance and pupil diameter.
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    K Number
    K982057
    Device Name
    BC 900 SLIT LAMP
    Manufacturer
    HAAG-STREIT AG
    Date Cleared
    1998-08-14

    (64 days)

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

    HAAG-STREIT AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used in the fitting of contact lenses and to aid in the diagnosis of diseases or trauma which affect the structural properties or topographic features of the anterior eye segment.
    Device Description
    The Haag-Streit brand BC 900 slit lamp is an instrument used for eye examination and the fitting of contact lenses. The device consists of a microscope combined with a light source that can be narrowed into a slit for illumination of the eye. Each is available with accessories to measure characteristics of the eye and to document actual shapes. The device is powered by 7 to 12V AC and 50-60 Hz.
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