Chrysalis Intelligence · Product Codes · QEA

QEA · Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Neurology · 5 clearances · 2 unique sponsors

Device class
Class II
Regulation 882.1455
Total clearances
5
2020-09-06 → 2026-06-05
Last 12 months
1
Unique sponsors
2
Definition

What is Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

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 intended for standalone detection or diagnostic purposes.
Medical specialty
Neurology
Review panel
NE
Regulation number
882.1455
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Oculogica, Inc. 4 1 2026-06-05
Syncthink, Inc. 1 0 2021-10-02
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
92260 CPT Medium Oculomotor evaluation with interpretation for neuro assessment
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-05 K254086 Oculogica, Inc. EyeBOX SNAP
2025-04-04 K242116 Oculogica, Inc. EyeBOX EBX-4.1
2021-12-22 K212310 Oculogica, Inc. EyeBOX (Model EBX-4)
2021-10-02 K202927 Syncthink, Inc. EYE-SYNC
2020-09-06 K201841 Oculogica, Inc. EyeBOX