K242116 is an FDA 510(k) clearance for the EyeBOX EBX-4.1. This device is classified as a Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid (Class II - Special Controls, product code QEA).
Submitted by Oculogica, Inc. (New Richmond, US). The FDA issued a Cleared decision on April 4, 2025, 259 days after receiving the submission on July 19, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1455. 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..
| 510(k) Number | K242116 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2024 |
| Decision Date | April 04, 2025 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QEA - Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1455 |
| 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. |