Samsung Medison V4–V8 diagnostic ultrasound systems gain FDA 510(k) clearance

The U.S. FDA has cleared the Samsung Medison V4, V5, V6, V7, and V8 diagnostic ultrasound system families via the 510(k) pathway.

• Clearance covers multiple model families including the V8, V7, V6, V5, and V4 series and their ONE variants.
• Regulatory pathway was a standard 510(k) premarket notification under radiology product code IYN.
• Specific performance metrics or clinical substantiation data are not disclosed in the FDA summary record.

Automated summary

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