QEA — Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid Class II
FDA product code QEA covers "Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid", a Class II medical device regulated under 21 CFR 882.1455. Submissions are reviewed by the Neurology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QEA
- Device Class
- Class II
- Regulation Number
- 882.1455
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254086 | oculogica | EyeBOX SNAP | June 5, 2026 |
| K242116 | oculogica | EyeBOX EBX-4.1 | April 4, 2025 |
| K212310 | oculogica | EyeBOX (Model EBX-4) | December 22, 2021 |
| K202927 | syncthink | EYE-SYNC | October 2, 2021 |
| K201841 | oculogica | EyeBOX | September 6, 2020 |
| K191183 | oculogica | EyeBOX | July 31, 2019 |
| DEN170091 | oculogica | EyeBOX | December 28, 2018 |