QEA
7 FDA 510(k) clearances · Product code
169 daysmedian time to decision
371 days90th percentile
7clearances measured
FDA profile
- Official device name
- Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1455
- Medical specialty
- Neurology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EyeBOX SNAP (K254086) | Oculogica, Inc. | 2026-06-05 |
| EyeBOX EBX-4.1 (K242116) | Oculogica, Inc. | 2025-04-04 |
| EyeBOX (Model EBX-4) (K212310) | Oculogica, Inc. | 2021-12-22 |
| EYE-SYNC (K202927) | Syncthink, Inc. | 2021-10-02 |
| EyeBOX (K201841) | Oculogica, Inc. | 2020-09-06 |
| EyeBOX (K191183) | Oculogica, Inc. | 2019-07-31 |
| EyeBOX (DEN170091) | Oculogica, Inc. | 2018-12-28 |
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Every clearance here is in the API, with alerts when new ones post.