FDA Clears E-Scopics ES-Series Radiology Device

FDA 510(k) clearance granted to E-Scopics for its ES-Series device under radiology product code IYN. Specific indications and predicate device not detailed in available clearance summary.

• 510(k) clearance (K260748) issued for the ES-Series by E-Scopics under FDA radiology product code IYN.
• Product code IYN covers diagnostic radiology imaging devices; exact clinical indication and predicate device not specified in the available summary.
• No clinical performance data (sensitivity, specificity, AUC) reported in the clearance notice — standard for 510(k) substantial-equivalence pathway.

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