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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
Regulation Description 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 Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 880.2750
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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