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The OFC100L is a high-resolution ophthalmic imaging device that is primarily intended for photographing the fundus of the eye with / without dilating the pupil. It is a prescription-use medical device only.
Oivi AS
OFC100L
In Commercial Distribution
- 00860010826812 ()
- Ophthalmic fundus camera
A collection of neuropsychological tests for health professionals and researchers. The assessment measures cognitive function and performs a complete cognitive screening, allowing users to quickly, conveniently, and accurately assess the well-being and cognitive profile of patients and research participants. Applicable via in-person consultation, in a laboratory setting, and remotely.
Cognifit, Inc.
PRO
In Commercial Distribution
- 00860009958104 ()
- Cognitive assessment software
No Description
Aural Analytics, Inc.
SVCOG
Not in Commercial Distribution
- 00860009693401 ()
- Cognitive assessment software
Neurotrack’s exam is a computerized cognitive exam delivered via mobile device or browser, intended to detect and track cognitive impairment in patients with existing cognitive impairment, subjective memory loss, or healthy individuals. The user will interact with the exam battery on a screen. Using visual cues, the user will touch the screen, trackpad or mouse to make a selection. Successful completion of the exam battery relies on use of the hands and eyes.
The device may be used by the patient in the home, or in a health clinic with or without supervision. The results are reviewed by a health care provider trained in nervous system conditions. Neurotrack’s digital cognitive assessment suite is not a stand-alone diagnostic tool and does not identify the absence or presence of any illness, condition, or disease. While Neurotrack’s digital cognitive assessment suite can be self-administered, any interpretation of scores should be discussed with a healthcare provider.
Neurotrack Technologies, Inc.
1.1.0
In Commercial Distribution
- 00860009484504 ()
- Cognitive assessment software
The Spect Ophthalmic Camera is a product consisting of an Apple iPhone, a mobile application (app), and an optical lens attachment and illumination source. The mobile app is accessible to users via the Apple App Store (Apple Inc.) for use on Spect issued iPhone devices. The Spect Ophthalmic Camera consists of a mechanical adaptor with a telescopic feature that houses a high-quality glass fundoscopic lens, and a white-light LED illumination source.
Spect Inc.
BOM001
In Commercial Distribution
- 00853501008002 ()
- Ophthalmic fundus camera
The Phoenix ICON GO is a portable, hand held, ophthalmic imaging device intended for general opthalmic imaging of the retina, cornea, and external structures of the eye.
Phoenix Clinical
PCI 40-2001
In Commercial Distribution
- 00857253006088 ()
- Ophthalmic fundus camera
White light module for the Phoenix Clinical ICON retinal imaging system.
Phoenix Clinical
PCI 40-1005
In Commercial Distribution
- 00857253006064 ()
- 00857253006095 ()
- 00857253006125 ()
PCI 40-1005
- Ophthalmic fundus camera
The Phoenix ICON retinal imaging system is a wide-field, handheld, high resolution, real time retinal imaging device. It is intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye.
Phoenix Clinical
PCI 40-1000
In Commercial Distribution
- 00857253006057 ()
- Ophthalmic fundus camera
The ICON is a wide-field high-resolution retinal imaging system optimized for pediatric patients to age 18. The image is captured using a hand-held corneal contact camera and is displayed in real-time. The camera contacts the cornea to image the retina and is connected to a cart with the power supplies, controls, computer and display unit. The light source for bright field imaging is a white-light LED located in the hand piece and the hand piece is connected to a mobile through a USB cable and cables for focus motor and LED light. Software in the computer performs library functions and can capture either still or video data. Data can be exported with or without patient information.
Phoenix Clinical
PJZ
In Commercial Distribution
- 00857253006040 ()
PCI-40-1000-P
- Ophthalmic fundus camera
Phoenix Clinical ICON Control Box
Phoenix Clinical
PCI 40-1003
In Commercial Distribution
- 00857253006026 ()
PCI 40-1003
- Ophthalmic fundus camera