FDA Clears DRE Duo Digital Radiographic/Fluoroscopic System from Jpi Healthcare

FDA 510(k) clearance for DRE Duo, a diagnostic radiographic/fluoroscopic system (product code KPR) from Jpi Healthcare Co., Ltd. No clinical performance data reported with this filing.

• Device: DRE Duo digital radiographic/fluoroscopic system, cleared via 510(k) (K260482).
• Manufacturer: Jpi Healthcare Co., Ltd.; predicate device not disclosed in source.
• Limitation: Clearance notice provides no imaging performance metrics or intended use details beyond product code.

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