Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
The Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid is a prescription device that uses a patient's tracked eye movements to provide an interpretation of the functional condition of the brain, intended as an adjunct assessment aid for traumatic brain injury and not for standalone detection or diagnostic purposes. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 882.1455 in the Neurology specialty. The product code is QEA. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QEA
- Device Class
- FDA class 2
- Regulation Number
- 882.1455
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K254086 | EyeBOX SNAP | Jun 05, 2026 | Substantially Equivalent | Oculogica, Inc. |
| K242116 | EyeBOX EBX-4.1 | Apr 04, 2025 | Substantially Equivalent | Oculogica, Inc. |
| K212310 | EyeBOX (Model EBX-4) | Dec 22, 2021 | Substantially Equivalent | Oculogica, Inc. |
| K202927 | EYE-SYNC | Oct 02, 2021 | Substantially Equivalent | Syncthink, Inc. |
| K201841 | EyeBOX | Sep 06, 2020 | Substantially Equivalent | Oculogica, Inc. |
| K191183 | EyeBOX | Jul 31, 2019 | Substantially Equivalent | Oculogica, Inc. |
| DEN170091 | EyeBOX | Dec 28, 2018 | Unknown | Oculogica, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.