Search Results

The Resolve Fundus Camera is an automatic eye-fundus camera intended for taking digital images of a human retina with or without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.

The Resolve Fundus Camera is a fundus camera designed to perform fundus observation, automatic pupil tracking and focusing, automatic image capture, and image preservation. The Resolve Fundus Camera is used for non-mydriatic observation and capturing of retinal images. The fundus camera employes three internal imaging systems to operate: illumination system, imaging system and observation system. Auto-alignment and auto-focus algorithms are used to automatically find and capture desired images of the fundus. The fundus camera features an internal, movable three-dimensional platform that allows for switching and precise positioning of the left and right eyes. The imaging process is done one eye at a time (left eye and then the right eye). The internal, moveable three-dimensional platform contains two types of cameras: a set of infrared cameras (one on each side) as well as one main camera. The observation system is used to detect and track the patient's pupil. Next, the illumination system determines the precise location of the ocular fundus after the pupil is located by the observation system. The system precisely finds the relationship between the position of the ocular fundus at different diopters, and the lens of the main camera. Once the location of the fundus is found, a charge-coupled device (CCD) automatically captures a still image of the fundus through the main camera. The autofocus system utilizes a beam splitter to split a beam of light into two fine beams, which then image the ocular fundus onto the CCD. When the focus is at its sharpest position, the split beams align horizontally. At this point, the LED white light illumination system, installed in the imaging module on the three-dimensional movable platform, emits uniform white light of appropriate intensity to illuminate the ocular fundus. The imaging system captures the fundus information onto the CCD, and the received signals are displayed in real-time on a liquid crystal display (LCD) through the control system. Doctors can visually assess the patient's ocular fundus on the LCD screen.

Sentinel Camera is a non-mydriatic medical digital camera that is intended to capture digital images of the human eye.

The Sentinel Camera is accompanied by the following accessories: a charging base, eye cup, and power cable. The Sentinel Camera is designed for use in a medical environment. Captured images are used for documentation and consultation. Sentinel Camera has internal memory where captured images are stored. The Sentinel Camera is designed for non-mydriatic retinal imaging. In non-mydriatic imaging no mydriasis is needed because infrared light is used for targeting the retina and white light is flashed when an image is taken. The pupil does not respond to the infrared light, so examination is convenient for the patient. With small pupils, it is recommended to use mydriatic drops. The Sentinel Camera has three internal fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-centered image. The left and right fixation targets provide disc-centered images. The transfer of images to the AI Optics Server is carried out via Wi-Fi communication. The Sentinel Camera has a rechargeable Li-ion battery that is charged when the camera is placed on charging base, which is connected to the mains by the power cable.

Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina segment of the eye to be evaluated under non-mydriatic conditions. Verily Numetric Retinal Camera is indicated for in-vivo viewing of the posterior segment of the eye. The images are intended for use as an aid to clinicians in the evaluation, diagnosis, and documentation of ocular health.

The Verily Numetric Retinal Camera (VNRC), the subject device, is a tabletop fundus camera that provides non-mydriatic, color, posterior segment images of the eye as an aid to clinicians in the evaluation and diagnosis of eye disease. It is a non-contact, high-resolution digital imaging device that is suitable for photographing, displaying, and storing images of the retina to be evaluated under non-mydriatic conditions. The Verily Numetric Retinal Camera takes images of the fundus in the following manner: Focusing: The patient interactively focuses an image shown on a microdisplay to the best qualitative focus by turning a knob on an external peripheral device which modulates the camera optics. Alignment: The patient is shown a fixation target on the microdisplay and through an interactive session with position feedback, the patient aligns their pupil to the camera. The pupil location is determined using eye-tracking. Image Capture: White light from LEDs illuminates the fundus. The light reflection from the fundus is captured by a color CMOS sensor.

Optina-4C™ is intended to capture images of the retina at multiple wavelengths (colors) under mydriatic conditions.

Optina-4C™ (model: MHRC-C1N) is a mydriatic fundus camera (also called retinal camera) that presents eye care practitioners (optometrists and ophthalmologists) with a series of the retina obtained sequentially at specific wavelengths (colors) in the spectral range 905 nm to 450 nm in steps of 5 nm. Pictures of the retina are obtained on a field-of-view of 31.5° without contact with the eye. The patient is positioned in front of the device with the chin on the chinrest and forehead on the forehead rest and a positioning system is used to align the camera relative to the patient's eye. An external fixation target is available to guide the patient's eye. A focus wheel allows for the accommodation for eye refractive error in the range of -15 to +15 diopters. The images are displayed on a monitor and can be saved on the computer for future consultation. The illumination light of Optina-4C™ is provided by a Tunable Laser Source (TLS). The TLS selects a narrow band of light from a broadband white illumination source. Only a single monochromatic band can output the TLS at a time. The alignment of the retinal camera relative to the patient's eye phase is performed with the illumination light set at a wavelength of 700 nm. The image acquisition phase consists of the sequential acquisition of a series of 92 monochromatic images at wavelengths from 905 nm in steps of 5 nm. Each frame is captured with an exposure time of 10 ms, resulting in a total acquisition time of 920 ms. The 92 images can be visualized one by one in Optina-4C™ acquisition software. The retinal images captured by Optina-4C™ are monochromatic images having a spectral bandwidth of "10 nm centered on the wavelength indicated in the upper left corner of the visualization pane, with a spectral accuracy of 7.5 nm.

Zilia Ocular is a non-contact imaging device for capturing, displaying and storing images of the retina under mydriatic conditions. Zilia Ocular is intended for use as an aid to clinicians in the evaluation and documentation of ocular health.

The Zilia Ocular Fundus Camera (Zilia Ocular FC) is a non-contact, stand-alone device designed to image the eye fundus. The device includes a base, a head support, an onboard computer with a 15.6'' touch-screen display and an optical head. A joystick, situated at the base of the device, controls the movements of the optical head to enable adequate positioning. The touch-screen display also includes a user interface allowing the user to control the device and acquire and display patient data and images. The Zilia Ocular FC uses near-infrared (NIR) light-emitting diodes (LEDs) as illumination during alignment to the patient's pupil, and a white LED during focusing and imaging of the eye fundus. The region of the eye fundus being imaged can be modified by changing or moving the fixation target. The images are saved and stored on the onboard computer. The dimensions of the Zilia Ocular FC are 620 mm (L) by 360 mm (W) by 500 mm (H) and it weighs about 32 kg.

General ophthalmic imaging including retinal, corneal, and external structures of the eye.

The Phoenix ICON system is an updated cart based retinal imaging system covering the design changes to date on the predicate device, Phoenix ICON. The Phoenix ICON GO retinal imaging system is a portable version of the predicate device, Phoenix ICON (K170527) including the design changes in the Phoenix ICON system. Both the Phoenix ICON and Phoenix ICON GO are wide-field, handheld, high resolution, real-time retinal imaging devices. They are intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye. The intended users of the Phoenix ICON and Phoenix ICON GO are clinical imaging technicians, ophthalmic technicians, nurses, and physicians. The devices may be used in hospitals, medical clinics, and physician's offices. The Phoenix ICON platform consists of either a cart based (Phoenix ICON) or portable (Phoenix ICON GO) control box used in conjunction with a hand-held camera (Handpiece) using interchangeable LED based light sources (White and Blue light). The Phoenix ICON cart contains an AC mains power attachment, a battery module, a keyboard interface, a monitor, and a computer with Phoenix ICON software. The Phoenix ICON GO contains a portable control box with battery function and has an interface for attachment to a specified laptop computer which runs the Phoenix ICON software. Both systems may be used with a Foot Pedal, White Light Module (standard), Blue Light Module (FA) and/or Diffuser accessory. The Phoenix ICON Handpiece contains a wide-field, high resolution camera is used in three (3) modes, External Imaging (White Light), Retinal Imaging (White Light), and Fluorescein Angiography (Blue Light). For external imaging, the Diffuser accessory is placed over the lens tip to diffuse the light and provide for images of the outer surfaces of the eye. Both Retinal Imaging and Fluorescein Angiography are performed with the glass lens of the Handpiece coupled to the cornea via an imaging gel. In these imaging methods, LED light is emitted into the eye to illuminate the retina for image capture. Both the Phoenix ICON and Phoenix ICON GO are software-controlled systems which can capture either video or still images and store them on the control box (Cart computer or GO laptop) for later review. The Phoenix ICON system may be connected to IT networks under IT supervision.

The iExaminer system with PanOptic Plus, consisting of PanOptic Plus, SmartClip, iExaminer application, and one of the following: iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro, is intended to be used to capture images as an aid to clinicians in the evaluation, and documentation of ocular health. The images from the iExaminer System with PanOptic Plus are not intended to be used as a sole means of diagnosis.

The iExaminer System with PanOptic Plus is a medical device that allows the user to capture images through the use of a PanOptic Plus ophthalmoscope and a smart device. The iExaminer System with PanOptic Plus consists of (also see Figure 1): 1. PanOptic Plus Ophthalmoscope: a. Ophthalmoscope Head b. Compatible energy sources (i.e. battery handles or wall units) c. Optional Patient Eyecup 2. Smart device attachment instrument (made of SmartBracket and SmartClip); 3. Compatible smart device (iPhone X, iPhone 11 Pro, iPhone 11 Pro Max, iPhone 12 Pro). 4. iExaminer Pro Software Application. The iExaminer system with PanOptic Plus is intended to take photographs of the eye and surrounding area.

Eyer® Retinal Camera model NM-STD is a medical non-mydriatic digital camera with a Samsung Galaxy S10 smartphone to capture digital images and videos of the funan eye, surface of the human eye and surrounding areas

The Eyer Retinal Camera NM-STD retinography is accompanied by accessories: dock station (1pc), lens protector (1 pc), allen wrench (1pc), eyecap (2 pcs) cleaning cloth (1 pc) and slit lamp adapter (1pc). Eyer Retinal Camera NM-STD is designed for use in a medical environment. Captured images and video are used for documentation. The images and videos are stored in an internal database of the smartphone application, in a security way. For the retinal function, Eyer Retinal Camera NM-STD is designed for non-mydriatic fundus imaging. In non-mydriatic imaging no mydriasis is needed because infrared light is used for targeting the fundus and white light is flashed when an image is taken. The pupil does not respond to the infrared light, so examination is convenient for the patient. With small pupils, it is recommended to use mydriatic drops. Eyer Retinal Camera NM-STD has eleven fixation targets for the patient to fixate on during imaging. The middle fixation target provides a macula-center image. It is possible to fix the center by selecting the appropriate point. For the anterior function, Eyer Retinal Camera NM-STD has a white light source for imaging eye surface and surrounding areas, in this configuration the device does not make contact with the patient. The transfer of images to a PC is carried out via FTP, DICOM or CFIS communication, with the client responsible for the connection and subsequent storage. The Eyer Retinal Camera NM-STD, energy comes from the smartphone that has a rechargeable Li-lon battery and is charged when the device is docked on charge station, which is connected to the mains by power supply cable.

The Non-Mydriatic Retinal Camera NW500 intended for use in capturing images of the retina and presenting the data to the eye care professional, without the use of a mydriatic.

The Non-Mydriatic Retinal Camera NW500 is a non-mydriatic and slit-scanning ophthalmic camera intended to capture, display and store images of the retina and the surrounding adnexa (the fundus oculi) to aid in the diagnosis. It has automatic functions such as auto-alignment, auto-focus, auto-shoot and auto-small pupil functions which can be switched ON/OFF or automatic/manual operation. Eyes with pupil diameters of 2.0mm or more are photographable with NW500. The digital cameras incorporated in the main unit capture images of the retina and the surrounding adnexa (the fundus oculi), and the control panel (LCD touch panel) their associated information (such as patient/test/photography information). The captured images (static images) can also be displayed on a commercially available monitor of a personal computer (hereafter called “PC”) by using the capturing software, Ez Capture for NW500 which is one of the accessories of NW500. The captured images (static images) and their associated information (such as patient/test/photography information) can be exported to and stored in commercially available USB flash drives, PCs, servers (such as a DICOM server) and shared network folders as electric data, and they can be printed out from commercially available printers.