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510(k) Data Aggregation

    K Number
    K210197
    Device Name
    NFC-600 Automated Portable Retinal Camera
    Manufacturer
    Crystalvue Medical Corporation
    Date Cleared
    2021-04-13

    (78 days)

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

    Crystalvue Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NFC-600 is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. NFC-600 is indicated for in-vivo viewing of the posterior and external area of the eye and the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.
    Device Description
    NFC-600 is a non-contact fundus camera for capturing, storing and displaying the color fundus images with 12 million pixels. It was designed a non-contact, images provide high resolution digital imaging device, auto 3D tracking, auto exposure, and auto capture functions, a portable device with auto-focusing technique and easy operation. Different from the all-in-one design (built-in PC module) of previous cleared product. NFC-600 removed the embedded computer module and designed to use the USB 2.0 port which is located behind the base to connect to the user's PC or laptop, making the device smaller and lighter to achieve a portable design. The dimensions of NFC-600 is about 330mm (L)x 260mm (W)x 330mm (H) and the whole weight not more than 12 kg. Same as the predicate device, NFC-600 uses NIR LED as illumination during alignment to the retina of patients' eyes. All operations are performed through the proprietary software, which will be installed in the user's PC or laptop to capture, store, view, retrieve, and export ophthalmic images.
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    K Number
    K182199
    Device Name
    NFC-700 non-mydriatic auto fundus camera
    Manufacturer
    Crystalvue Medical Corporation
    Date Cleared
    2019-01-02

    (141 days)

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

    Crystalvue Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NFC-700 is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. NFC-700 is indicated for in-vivo viewing of the posterior and external area of the eye and the images are intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health.
    Device Description
    The NFC-700 is a non-contact fundus camera for capturing, storing and displaying the color fundus images with 12MP. It was designed a non-contact, high resolution digital imaging device, auto 3D tracking, fast and easy to use retinal imaging system and provide images of the eye as an aid to clinicians in the diagnosis of diabetic retinopathy, AMD, glaucoma and other retinal diseases. NFC-700 was designed as an All-in-one system with full auto-focusing technique and easy operation. The large 10.1" touch screen makes it easy to control all of the operating procedures and makes the measurement and image check easily. NFC-700 uses NIR LED as illumination during alignment to the retina of patients' eyes, users can just touch the center of the pupil on the screen to capture the image. There also some interface located at the bottom of the device such as USB, HDMI, Ethernet make user to store, retrieve, archive and share the digital images by USB or LAN.
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    K Number
    K180820
    Device Name
    Tono Vue Non-Contact Tonometer
    Manufacturer
    Crystalvue Medical Corporation
    Date Cleared
    2018-12-14

    (260 days)

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

    Crystalvue Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TonoVue is a non-contact tonometer that is intended to measure the intraocular pressure of the human eye in vivo. The TonoVue is a non-contact tonometer that intended to measure the intra-ocular pressure of the eye in patients with less than 3 diopters of corneal astigmatism.
    Device Description
    TonoVue Tonometer is designed to non-contact tonometer (NCT) that measures the intraocular pressure (IOP) by delivering a soft air puff without contacting eyes directly. It's designed as a full auto-alignment and All-In-One desktop type medical device with built-in thermal line printer. The dimensions of whole device are about 500mm (H) x 260mm (W) x 500mm (L). The AC power input port and a USB port are set at the bottom side of the device, but the USB port only for engineering use. Based on the Imbert-Fick principle, the IOP is calculated by dividing the amount of air pressure into the area of applanated surface. TonoVue utilizes a rapid air puff to apply force for flattening the cornea of human eye, and an advanced electro-optical system to monitor its deformation. The puff force increases until the cornea is applanated over the predetermined area and detected by the pressure sensor inside TonoVue, and the IOP can be calculated.
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