K120949 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. (Philedelphia, US). The FDA issued a Cleared decision on January 11, 2013, 287 days after receiving the submission on March 30, 2012.
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 | K120949 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2012 |
| Decision Date | January 11, 2013 |
| Days to Decision | 287 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. |