Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Device Code: 3808
Product Code(s):
QEA Definition: A Traumatic Brain Injury Eye Movement Assessment Aid Is A Prescription Device That Uses A Patient’s Tracked Eye Movements To Provide An Interpretation Of The Functional Condition Of The Patient’s Brain. This Device Is An Assessment Aid That Is Not In
Device Classification Information
| Device Type ID | 3808 |
| Device Name | Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid |
| Physical State | The Device Has A Screen That Displays A Stimulus For The Patient's Eyes To Follow During The Exam. An Eye Tracking Camera Measures The Eye Movements For The Duration Of The Exam. A Computer Applies An Analysis Algorithm To The Tracked Eye Movements. |
| Technical Method | Performs An Analysis Of A Patient's Tracked Eye Movements To Assess Their Functional Brain Injury Status. |
| Target Area | The Device Measures Eye Movements To Assess Brain Function. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.1455 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QEA |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3808 |
| Device | Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid |
| Product Code | QEA |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 882.1455 [🔎] |
TPLC Last Update: 2019-04-02 20:37:17