K211617 is an FDA 510(k) clearance for the Infrascanner. 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 February 9, 2022, 259 days after receiving the submission on May 26, 2021.
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 | K211617 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2021 |
| Decision Date | February 09, 2022 |
| Days to Decision | 259 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. |