FDA Clears Dosisoft ThinkQA 3 Radiation Therapy QA Software

FDA 510(k) clearance granted to Dosisoft SA for ThinkQA 3, a radiation therapy quality assurance software system (product code IYE). Intended to support dosimetry QA workflows in radiotherapy planning and delivery.

• ThinkQA 3 is a radiotherapy QA software platform developed by Dosisoft SA, cleared under FDA 510(k) pathway (product code IYE).
• Product code IYE covers software used in radiation therapy treatment planning and quality assurance; no clinical performance numbers (sensitivity/specificity) are typically required or reported for this device class.
• Clearance is a regulatory milestone; independent clinical validation data are not reported in the FDA clearance summary.

Automated summary

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