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U.S. Department of Health and Human Services

Product Classification

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Device 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 CodePBZ
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch Two - Surgical (GSDB2)
Submission Type 510(k)
Regulation Number 880.2750
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible