| Device |
infrared hematoma detector |
| Regulation Description |
Near Infrared (NIR) Brain Hematoma Detector. |
| Definition |
To employ near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas. |
| 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 Medical Specialty |
Ophthalmic |
| Review Panel |
Neurology |
|---|
| Product Code | OPT |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.1935
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
