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Updated: Feb 16, 2026
Controlled Microfluidic Environment for Dynamic Investigation of Red Blood Cell Aggregation
Published on: June 4, 2015
Medical Devices; General Hospital and Personal Use Devices; Classification of the Image Processing Device for
Abstract:
The Food and Drug Administration (FDA or we) is classifying the image processing device for estimation of external blood loss into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the image processing device for estimation of external blood loss' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
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Pre-Procedural Guidelines for Doppler Ultrasound Blood Pressure Assessment:
Preparation of Equipment: