Neurology · De Novo · 2018
EyeBOX
Oculogica, Inc.. Granted by FDA on 28 December 2018 under submission DEN170091, product code QEA (brain injury adjunctive interpretive oculomotor assessment aid). What FDA's record says, in FDA's words.
Device record · DEN170091
- Device. EyeBOXDEVICE
- Company. Oculogica, Inc.COMPANY
- Decision. 28 December 2018, De NovoDECISION
- Panel. NeurologyPANEL
- Product code. QEA, Brain Injury Adjunctive Interpretive Oculomotor Assessment AidCODE
- Regulation. 21 CFR 882.1455, Class IIREG
- Source. FDA database entry · decision document (14 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
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. L IMITATIONS For prescription use only. The EyeBOX device should not be used as a standalone assessment of concussion. The safety and effectiveness of the EyeBOX device has not been established in patients suspected of having moderate or severe TBI, including patients with a Glasgow Coma Scale score less than 13 and patients with evidence of structural injury or intracranial hemorrhage as determined by imaging modalities. The safety and effectiveness of the EyeBOX device has not been established in patients who have incurred an injury more than 1 week before assessment with the EyeBOX. The safety and effectiveness of the EyeBOX device has not been established in patients who have any of the following: • Have visual acuity worse than 20/80 • Have a history of disordered eye movement (including strabismus, diplopia, and amblyopia) • Have conditions that affect the eye tissue, including retinal degeneration, cataracts, and corneal scarring • Have abnormal function of cranial nerves III, IV, or IV • Are […]
The product code's definition, from FDA's classification record. A traumatic brain injury eye movement assessment aid is a prescription device that uses a patients tracked eye movements to provide an interpretation of the functional condition of the patients brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionsprescription use
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QEA. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QEA, in Neurology, from Oculogica, Inc., or granted in 2018. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.