Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Toshiba Medical Systems Coporation, Japan · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
140 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121422 | APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM | Toshiba Medical Systems Coporation, Japan | 2012-08-16 | 94 | 0 |
| K113466 | AQUILION ONE | Toshiba Medical Systems Coporation, Japan | 2012-04-10 | 140 | 3 |
| K112366 | 4CH FLEX SPEEDER | Toshiba Medical Systems Coporation, Japan | 2011-09-15 | 29 | 0 |
| K110785 | KALARE DIAGNOSTIC X-RAY TABLE SYSTEM | Toshiba Medical Systems Coporation, Japan | 2011-05-27 | 67 | 1 |
| K111251 | 4CH FLEX SPEEDER | Toshiba Medical Systems Coporation, Japan | 2011-05-27 | 23 | 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