Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Regulation 882.1455
1510(k)s in 12 months (7 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in QEA
| Company | 510(k)s | Recalls |
|---|---|---|
| Oculogica, Inc. | 6 | 1 |
| NeuroSync, Inc. | 0 | 1 |
| Syncthink, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 5, 2026 | K254086 | EyeBOX SNAP Oculogica, Inc. | QEA |
| Apr 4, 2025 | K242116 | EyeBOX EBX-4.1 Oculogica, Inc. | QEA |
| Dec 22, 2021 | K212310 | EyeBOX (Model EBX-4) Oculogica, Inc. | QEA |
| Oct 2, 2021 | K202927 | EYE-SYNC Syncthink, Inc. | QEA |
| Sep 6, 2020 | K201841 | EyeBOX Oculogica, Inc. | QEA |
| Jul 31, 2019 | K191183 | EyeBOX Oculogica, Inc. | QEA |
| Dec 28, 2018 | DEN170091 | EyeBOX Oculogica, Inc. | QEA |
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