FDA Clears Hitachi High-Tech PROBEAT-CR Radiology Device

FDA 510(k) clearance granted to Hitachi High-Tech Corp. for the PROBEAT-CR under product code LHN. Specific indications and predicate device not detailed in available source data.

• Device: PROBEAT-CR, manufacturer Hitachi High-Tech Corp.; cleared under FDA 510(k) pathway (K260174), product code LHN, classified under Radiology devices.
• Product code LHN covers computed radiography systems; the PROBEAT-CR is positioned in this category, though exact clinical indications and predicate device are not specified in the available snippet.
• Limitation: Full 510(k) summary not available in source excerpt — intended use, predicate device, and performance testing details not reported.

Automated summary

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