Definition: To Employ Near-infrared Spectroscopy That Is Intended To Be Used To Evaluate Suspected Brain Hematomas.
| Device Type ID | 3811 |
| Device Name | Infrared Hematoma Detector |
| Physical State | This Is A Standard Infrared Handheld Laser That Is Scanned Across The Scalp. The Information Is Transmitted To A Handheld Personal Digital Assistant That Displays Optical Density Measurements |
| Technical Method | Use Of Low Level Infrared Laser Radiation To Detect Hemoglobin Concentration Which Relates To Presence Of A Hemotoma. |
| Target Area | To Be Used On The Head. The Testing Divides The Head Into 8 Sections Four On The Left Side And The Corresponding 4 Sites On The Right Side. |
| Regulation Description | Near Infrared (NIR) Brain Hematoma Detector. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.1935 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OPT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3811 |
| Device | Infrared Hematoma Detector |
| Product Code | OPT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Near Infrared (NIR) Brain Hematoma Detector. |
| CFR Regulation Number | 882.1935 [🔎] |