Device class
Class II
Regulation 882.1935
Total clearances
3
2020-07-10 → 2024-12-12
Definition
What is Infrared Hematoma Detector
To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.
Classification details
Medical specialty
Ophthalmic
Regulation number
882.1935
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
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.
| Code | Type | Description | Confidence | Rationale |
| 92004 |
CPT
|
— |
Medium
|
Comprehensive eye and visual system examination, new patient; with initiation of diagnostic and treatment program |
| 99000 |
CPT
|
— |
Low
|
Handling and/or conveyance of specimen for transfer from the office to a laboratory |
Pulse
Most recent 510(k) clearances