510(k) K242116
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2025
- Date Received
- July 19, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
- Device Class
- Class II
- Regulation Number
- 882.1455
- Review Panel
- NE
- Submission Type
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.