Identity
- Trade Name
- EyeBOX FDA UDI
- Generic Name
- Eye-tracking neurological/brain injury assessment device FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- OCL 02.5 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810051680003 FDA UDI
- 510(k) Number
- K201841 FDA UDI
- FDA Product Code
- QEA FDA UDI
- GMDN Term
- Eye-tracking neurological/brain injury assessment device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1455 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Eye-tracking neurological/brain injury assessment device
EyeBOX by Oculogica Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Oculogica Inc.
Sources (1)
- FDA UDI 1b115526-476b-47f6-92d7-147dbd86263d 35 fields · synced Jun 8, 2026