510(k) K202927 ยท QEA Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
EYE-SYNC
| Applicant | Syncthink, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Oct 2, 2021 |
| Received | Sep 29, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202927
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.