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510(k) Data Aggregation

    K Number
    K102859
    Device Name
    RETCAM 3 OPTHALMIC IMAGING SYSTEM
    Manufacturer
    CLARITY MEDICAL SYSTEMS
    Date Cleared
    2011-04-20

    (202 days)

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

    CLARITY MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - General ophthalmic imaging including retinal, corneal, and external imaging. . - Photodocumentation of pediatric ocular diseases including retinopathy of prematurity (ROP). ♥ - Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, . without plus disease, or zone 2, stage 3, without plus disease) or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or Zone 2, stage 2 or 3, with plus disease) or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease)* in 35-37 week postmenstrual infants.
    Device Description
    The RetCam 3 Ophthalmic Imaging System utilizes a digital camera in a handpiece with multiple field of view lenses to capture color ophthalmic digital images including retinal, corneal, and external images. An on board computer is used to store, view, retrieve, and export the digital ophthalmic images. A standard Halogen light source is used to provide illumination to the eye through the handpiece. An optional Xenon light source is also available with the RetCam 3 to facilitate imaging with fluorescein angiography. Light intensity, camera focus, and image capture are controlled by the use of a RetCam 3 footswitch and can also be controlled by a keyboard on the RetCam 3 consoles. A console monitor is provided with the RetCam 3 for viewing images. Proprietary software is installed in the computer to capture, store, view, retrieve, and export ophthalmic images. A device modification to the RetCam 3 is being made to replace the Xenon light source module with an LED light source module. Third party testing has been performed and formal certification has been obtained verifying compliance with the applicable IEC 60601 electrical safety and electromagnetic compatibility standards. Bench testing has verified comparable safe maximum light irradiance output of the Xenon and LED light source modules. Bench testing has verified comparable fluoresce dye responses to the Xenon and LED light sources.
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    K Number
    K090326
    Device Name
    RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS
    Manufacturer
    CLARITY MEDICAL SYSTEMS
    Date Cleared
    2009-11-25

    (289 days)

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

    CLARITY MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Each and all above listed RetCam Systems are indicated for: - General ophthalmic imaging including retinal, corneal, and external imaging; . - Photodocumentation of pediatric ocular diseases including retinopathy of prematurity (ROP). . - Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, . without plus disease, or zone 2, stage 3, without plus disease) or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or 3, with plus disease) or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease)* in 35-37 week postmenstrual infants.
    Device Description
    RetCam Ophthalmic Imaging Systems utilize a digital camera in a handpiece with multiple field of view lenses to capture color ophthalmic digital images including retinal, corneal, and external images. An on board computer (RetCam II and RetCam 3) or laptop computer (RetCam Shuttle and RetCam Portable) is used to store, view, retrieve, and export the digital ophthalmic images. A standard Halogen light source is used in all RetCam configurations to provide illumination to the eye through the handpiece. An optional Fluorescein light source is also available with the RetCam II and RetCam 3 configurations. Light intensity, camera focus, and image capture are controlled by the use of a footswitch on all configurations and can also be controlled by a keyboard on the RetCam II and RetCam 3 consoles. Console monitors are provided with the RetCam II and RetCam 3 configurations for viewing images. The laptop monitor is used for viewing images with the RetCam Shuttle and RetCam Portable. Proprietary software is installed on the computers to capture, store, view, retrieve, and export ophthalmic images.
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    K Number
    K083771
    Device Name
    RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP
    Manufacturer
    CLARITY MEDICAL SYSTEMS
    Date Cleared
    2009-01-30

    (43 days)

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

    CLARITY MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RetCam Portable Ophthalmic Imaging System is indicated for general ophthalmic imaging including retinal, corneal and external imaging.
    Device Description
    The RetCam Portable Imaging System is designed to quickly and easily capture wide field, digital images and videos of the eye. The optional hard side or soft side packaging allows for easy transport from one location to another within or outside the hospital or clinic. The reduced packaging dimensions enhance the ease of use in confined space situations.
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    K Number
    K081858
    Device Name
    RETCAM 3 OPHTHALMIC IMAGING SYSTEM
    Manufacturer
    CLARITY MEDICAL SYSTEMS
    Date Cleared
    2008-11-05

    (127 days)

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

    CLARITY MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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