Konica Minolta's Universal 1417PI Digital Radiography Detector Receives FDA 510(k) Clearance

FDA has cleared the Universal 1417PI flat-panel DR detector from Konica Minolta Healthcare Americas under product code MQB. A 14×17-inch format general radiography detector; predicate device and specific technical specifications not reported in source.

• 510(k) clearance (K252996) granted for the Universal 1417PI under product code MQB, which covers computed/digital radiography image-acquisition systems for general radiology use.
• Manufacturer is Konica Minolta Healthcare Americas, Inc.; the 14×17-inch panel size is standard for full-field chest and skeletal radiography applications.
• No clinical performance data, sensitivity/specificity figures, or predicate device identity were included in the clearance summary available from the source.

Automated summary

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