EyeBOX (Model EBX-4)
Oculogica, Inc.
OCULOGICA INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014535677 | 3014535677 | OCULOGICA INC. | 1 | N | 2026-01-01 | 1477 South Knowles Avenue Suite 110F New Richmond WI US 54017 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 227312 | 1285104075 | K242116 | EyeBOX EBX-4.1 | QEA | 2025-04-04 |
| 227312 | 1247914097 | K212310 | EyeBOX (Model EBX-4) | QEA | 2021-12-22 |
| 227312 | 1418848794 | K201841 | EyeBOX | QEA | 2020-09-06 |
| 227312 | 1087694157 | K191183 | EyeBOX | QEA | 2019-07-31 |
| 227312 | 1194576706 | DEN170091 | EyeBOX | QEA | 2018-12-28 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QEA | 6 | 2025-04-04 |
PMN#
GUDID#
EyeBOX - DMR-0004
2026-05-19
EyeBOX - Oculogica’s EyeBOX uses eye-tracking technology and a data processing algorithm to detect subtle changes in eye movements resulting from concussion. The eye tracking task involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high speed near- infrared (IR) camera records gaze positions. The post-processed data are analyzed automatically to produce one or more outcome measures. The device is comprised of a host PC with integrated touchscreen interface for the operator, eye tracking camera, LCD stimulus screen and head-stabilizing rest (chin rest and forehead rest) for the patient, and data processing algorithm.The EyeBOX device tracks a patient’s eye movement and calculates a BOX Score ranging from 0-20. A score of less than 10 is a negative result, while a score of greater than or equal to 10 indicates a positive result.
2021-09-21