Mindray Resona and Nuewa ultrasound platforms receive FDA 510(k) clearance

FDA clears Mindray's Resona I10, I10W, I10 Exp, I10S, XI, and I10 CV, plus Nuewa I10, I10W, I10 Exp, I10S, and XI diagnostic ultrasound systems via 510(k) for general imaging.

• The clearance encompasses multiple configurations across the Resona and Nuewa product lines.
• The devices are classified as pulsed echo imaging systems (FDA product code IYN) for general diagnostic use.
• No specific clinical performance claims or quantitative metrics were disclosed in the regulatory record.

Automated summary

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