PBZ

Image Processing Device For Estimation Of External Blood Loss

Product code

PBZ

Device name

Image Processing Device For Estimation Of External Blood Loss

Device class

Class 2

21 CFR

21 CFR 880.2750

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

6 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-03-16.

2 summaries are archived here for direct download.