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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2025 | NeuroSync, Inc. NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a portable field cas Open, Classified |
QEA | K202927 |
| Apr 16, 2019 | OCULOGICA EyeBOX Model OCL 02 Terminated |
QEA | None listed |
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