Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shimadzu Corporation — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
136 daysmedian FDA review time
470 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252099 | Trinias | Shimadzu Corporation | 2026-03-24 | 264 | 0 |
| K233719 | FDR Visionary Suite | Shimadzu Corporation | 2024-03-28 | 128 | 0 |
| K233722 | RADspeed Pro | Shimadzu Corporation | 2024-02-23 | 94 | 1 |
| K191877 | FLUOROspeed | Shimadzu Corporation | 2019-08-05 | 21 | 1 |
| K190373 | SonialVision G4 | Shimadzu Corporation | 2019-03-15 | 24 | 1 |
| K173517 | RADspeed fit | Shimadzu Corporation | 2018-03-30 | 136 | 0 |
| K152294 | FDR Visionary Suite | Shimadzu Corporation | 2016-07-15 | 337 | 3 |
| K152244 | RADspeed Pro | Shimadzu Corporation | 2016-06-20 | 315 | 1 |
| K123508 | TRINIAS | Shimadzu Corporation | 2014-02-26 | 470 | 4 |
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