Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Siemens Medical Solution — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121513 | MULTIX FUSION | Siemens Medical Solution | 2012-08-10 | 81 | 1 |
| K121138 | ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solution | 2012-05-17 | 34 | 0 |
| K061449 | SYNGO EXPERT-1 | Siemens Medical Solution | 2006-07-25 | 61 | 0 |
| K050199 | MAGNETOM SYMPHONY A TIM SYSTEM | Siemens Medical Solution | 2005-02-18 | 21 | 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