Eye-tracking brain injury assessment device
Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Offentlige vurderingsrapport
(PAR)
21-04-2021
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Tilgængelig fra:
TBI diagnostics Pty Ltd
Klasse:
Class IIa
Fremstillet af:
Oculogia Inc 33 Irving Place, New York, New York, 10003 United States Of America
Terapeutisk område:
65064 - Eye-tracking brain injury assessment device
Terapeutiske indikationer:
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.
Autorisation status:
A
Autorisation dato:
2021-04-19
