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 |