# Image Processing Device For Estimation Of External Blood Loss
> **Product code: PBZ** · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.2750
## Classification
- **FDA Product Code:** PBZ
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 880.2750
- **Review panel:** SU
- **Medical specialty:** General Hospital
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 6
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PBZ)
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