Image Processing Device For Estimation Of External Blood Loss

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

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown