| Device |
image processing device for estimation of external blood loss |
| Regulation Description |
Image processing device for estimation of external blood loss. |
| Definition |
An image processing device for estimation of external blood loss is a device to be used as an aid in estimation of patient external blood loss. The device may include software and/or hardware that is used to process images capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images. |
| Physical State |
Software and Hardware system. |
| Technical Method |
A software algorithm analyzes recorded images of surgical sponges to estimate hemoglobin mass. |
| Target Area |
General Surgery |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | PBZ |
|---|
| Premarket Review |
Infection Control and Plastic and Reconstructive Surgery Devices
(DHT4B)
Infection Control and Plastic and Reconstructive Surgery Devices
(DHT4B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.2750
|
|---|
| 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 |
