OPT — Infrared Hematoma Detector Class II
Classification Details
- Product Code
- OPT
- Device Class
- Class II
- Regulation Number
- 882.1935
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241389 | infrascan | Infrascanner Model 2500 (Model 2500) | December 12, 2024 |
| K211617 | infrascan | Infrascanner | February 9, 2022 |
| K200203 | infrascan | Infrascanner | July 10, 2020 |
| K120949 | infrascan | INFRASCANNER | January 11, 2013 |
| DEN100002 | infrascan | INFRASCANNER, MODEL 1000 | December 13, 2011 |