K242618 is an FDA 510(k) clearance for the Layer 7-T. This device is classified as a Electrode, Cortical (Class II - Special Controls, product code GYC).
Submitted by Precision Neuroscience, Corp. (Mountain View, US). The FDA issued a Cleared decision on March 30, 2025, 208 days after receiving the submission on September 3, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1310.
| 510(k) Number | K242618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2024 |
| Decision Date | March 30, 2025 |
| Days to Decision | 208 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GYC - Electrode, Cortical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1310 |