ThinkQA 3
FDA 510(k) K252937 · Dosisoft SA
510(k) numberK252937
Submission
- Device name
- ThinkQA 3
- Applicant
- Dosisoft SA
Cachan, FR - Received
- September 15, 2025
- Decision date
- June 12, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was ThinkQA 3 cleared by the FDA?
ThinkQA 3 (K252937) received a 510(k) decision of Substantially Equivalent on June 12, 2026, 270 days after the submission was received.
What is the product code of K252937?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.