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No Description
Aural Analytics, Inc.
SVCOG
Not in Commercial Distribution
- 00860009693401 ()
- Cognitive assessment software
No Description
RETIVUE, LLC
WFP-B-G1.5-0A
In Commercial Distribution
- 00860011978305 ()
- Ophthalmic fundus camera
No Description
Qr8 Health Inc
SNP-COG-24
In Commercial Distribution
- 00860011850922 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
MSPT-W310
In Commercial Distribution
- 00860011850915 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
MSPT-311
In Commercial Distribution
- 00860011850908 ()
- Cognitive assessment software
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
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 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.
Optain Health, Inc.
Resolve Fundus Camera
In Commercial Distribution
- 00860014304507 ()
- Ophthalmic fundus camera
The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module. This model includes a well counter with 2 inch of lead shielding.
Mirion Technologies (capintec), Inc.
5430-30154
In Commercial Distribution
- 00859942006423 ()
5430-30154
- Thyroid-uptake nuclear medicine system
The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, Bioassay module, Wipe Test Module, and Lab Tests.
Mirion Technologies (capintec), Inc.
Captus 4000e Thyroid System with Well
In Commercial Distribution
- 00859942006102 ()
5430-30152
- Thyroid-uptake nuclear medicine system