Product Classification

• 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 Code: PBZ
• Premarket Review: Office of 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