K241389 is an FDA 510(k) clearance for the Infrascanner Model 2500 (Model 2500). This device is classified as a Infrared Hematoma Detector (Class II - Special Controls, product code OPT).
Submitted by Infrascan, Inc. (Philadelphia, US). The FDA issued a Cleared decision on December 12, 2024, 211 days after receiving the submission on May 15, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1935. To Employ Near-infrared Spectroscopy That Is Intended To Be Used To Evaluate Suspected Brain Hematomas..
| 510(k) Number | K241389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2024 |
| Decision Date | December 12, 2024 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OPT - Infrared Hematoma Detector |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1935 |
| Definition | To Employ Near-infrared Spectroscopy That Is Intended To Be Used To Evaluate Suspected Brain Hematomas. |