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 B
| Device Type ID | 5476 |
| Device Name | Image Processing Device For Estimation Of External Blood Loss |
| 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 Description | Image Processing Device For Estimation Of External Blood Loss. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.2750 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PBZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5476 |
| Device | Image Processing Device For Estimation Of External Blood Loss |
| Product Code | PBZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Image Processing Device For Estimation Of External Blood Loss. |
| CFR Regulation Number | 880.2750 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GAUSS SURGICAL, INC. | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 2 | |