ThinkQA 3— 510(k) K252937

Name: FDA 510(k) clearance K252937
Creator: U.S. Food and Drug Administration
Published: 2026-06-12

Substantially Equivalent

Dosisoft SA

FDA 510(k) clearance K252937 for ThinkQA 3, Substantially Equivalent on 2026-06-12. Applicant: Dosisoft SA. Device class: 2.

Clearance details

Applicant: Dosisoft SA
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2025-09-15
Decision date: 2026-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cachan, FR

Download summary PDF View on FDA.gov ↗

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More clearances from Dosisoft SA

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K241765 — PLANET Onco Dose (3.2)2025-03-14
K231573 — ThinkQA (Edition 2)2024-01-18
K112723 — EPIGRAY2012-02-08
K103146 — ISOGRAY TREATMENT PLANNING SYSTEM2011-03-11

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.