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510(k) Data Aggregation

    K Number
    K221601
    Device Name
    MS-39
    Manufacturer
    C.S.O. S.r.l.
    Date Cleared
    2023-09-01

    (456 days)

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

    C.S.O. S.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MS-39 is designed to capture scans of the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens of the eye. To evaluate: - anterior and posterior corneal shape (elevation maps, curvature maps, power maps); - anterior chamber features (Anterior Chamber Depth ACD, Aqueous Depth AD); - corneal thickness (Central Corneal Thickness CCT, corneal thickness map); - corneal epithelia map; - corneal stroma map; - lens thickness.
    Device Description
    Not Found
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    K Number
    K132987
    Device Name
    COBRA FUNDUS CAMERA
    Manufacturer
    C.S.O. S.R.L.
    Date Cleared
    2014-07-03

    (282 days)

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

    C.S.O. S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CSO Cobra Fundus Camera is intended for taking digital images of a human retina with or without the use of mydriatic agent. The retinal image can be stored to an image filing device.
    Device Description
    Cobra is intended for taking digital images of a human retina with or without the use of a mydriatic agent. A function for retinal plane capturing is provided. The instrument is furnished with an integrated 5MP CCD camera, and uses one (1) white LED for flashing, one (1) IR led for alignment and Infrared acquisitioning. Cobra can be used with pupil diameters starting from 2.5 mm, and therefore can be used without the need for a mydriatic agent. Acquisition transfer is performed from the instrument to the accompanying PC via a Firewire cable.
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    K Number
    K022054
    Device Name
    F 900
    Manufacturer
    C.S.O. S.R.L.
    Date Cleared
    2002-08-06

    (43 days)

    Product Code
    HKY
    Regulation Number
    886.1930
    Why did this record match?
    Applicant Name (Manufacturer) :

    C.S.O. S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A manual device intended to measure intraocular pressure by applanation (applying a small flat disk to the cornea)
    Device Description
    Not Found
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