ThinkQA 3— 510(k) K252937
Substantially EquivalentDosisoft SA
FDA 510(k) clearance K252937 for ThinkQA 3, Substantially Equivalent on 2026-06-12. Applicant: Dosisoft SA. Device class: 2.
Summary
Dosisoft's ThinkQA 3 is filed under IYE, medical linear accelerators. The record doesn't describe ThinkQA 3 beyond its name and the code name.
Class II, 21 CFR 892.5050. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
Dosisoft filed from Cachan, France. The decision came 270 calendar days after FDA received it (September 15, 2025 to June 12, 2026).
Clearance details
- Applicant
- Dosisoft SA
- Product code
- Product code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cachan, FR
Recent devices under product code IYE
view allMore clearances from Dosisoft SA
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.