GeneralDevices & AI clearances

FDA clears Quantified Imaging Limited's Perfusion Measurement Platform v1

FDA 510(k) — Radiology devicesJun 22

FDA has granted 510(k) clearance to Quantified Imaging Limited's Perfusion Measurement Platform v1, a radiology image processing system (product code LLZ) for perfusion analysis. Exact clinical indications not disclosed in the clearance summary.

  • Device: Perfusion Measurement Platform v1, a software tool for perfusion imaging analysis in radiology.
  • Manufacturer: Quantified Imaging Limited. Clearance type: 510(k) premarket notification.
  • Specific clinical indications, predicate device, and performance data were not provided in the FDA summary.
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