OPT
5 FDA 510(k) clearances · Product code
259 daysmedian time to decision
614 days90th percentile
5clearances measured
FDA profile
- Official device name
- Infrared Hematoma Detector
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1935
- Medical specialty
- Ophthalmic
- FDA definition
- To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Infrascanner Model 2500 (Model 2500) (K241389) | Infrascan, Inc. | 2024-12-12 |
| Infrascanner (K211617) | Infrascan, Inc. | 2022-02-09 |
| Infrascanner (K200203) | Infrascan, Inc. | 2020-07-10 |
| INFRASCANNER (K120949) | Infrascan, Inc. | 2013-01-11 |
| INFRASCANNER, MODEL 1000 (DEN100002) | Infrascan, Inc. | 2011-12-13 |
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Every clearance here is in the API, with alerts when new ones post.