Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Siemens Medical Solution, Inc. USA · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050476 | CORDLESS COIL | Siemens Medical Solution, Inc. USA | 2005-03-25 | 29 | 0 |
| K050297 | SOMATOM EMOTION 16 | Siemens Medical Solution, Inc. USA | 2005-03-01 | 22 | 3 |
| K042229 | SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE | Siemens Medical Solution, Inc. USA | 2004-09-01 | 15 | 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