Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Dosisoft SA — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
232 daysmedian FDA review time
270 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252937 | ThinkQA 3 | Dosisoft SA | 2026-06-12 | 270 | 0 |
| K241765 | PLANET Onco Dose (3.2) | Dosisoft SA | 2025-03-14 | 267 | 0 |
| K231573 | ThinkQA (Edition 2) | Dosisoft SA | 2024-01-18 | 232 | 0 |
| K112723 | EPIGRAY | Dosisoft SA | 2012-02-08 | 142 | 0 |
| K103146 | ISOGRAY TREATMENT PLANNING SYSTEM | Dosisoft SA | 2011-03-11 | 137 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda