Eye-tracking brain injury assessment device
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
21-04-2021
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Available from:
TBI diagnostics Pty Ltd
Class:
Class IIa
Manufactured by:
Oculogia Inc 33 Irving Place, New York, New York, 10003 United States Of America
Therapeutic area:
65064 - Eye-tracking brain injury assessment device
Therapeutic indications:
The EyeBOX is intended to measure and analyze eye movements as an aid in the diagnosis of concussion within one week of head injury in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion. A negative EyeBOX classification may correspond to eye movement that is consistent with a lack of concussion. A positive EyeBOX classification corresponds to eye movement that may be present in both patients with or without concussion.
Authorization status:
A
Authorization date:
2021-04-19
