Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Siemens Medical Solutions Health Services Corporat · 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) |
|---|---|---|---|---|---|
| K061590 | SMDIE DEVICE INTERFACING SYSTEM | Siemens Medical Solutions Health Services Corporat | 2006-06-21 | 13 | 0 |
| K946117 | MEDICAL IMAGE MANAGEMENT SYSTEM (MIM) | Siemens Medical Solutions Health Services Corporat | 1995-03-02 | 77 | 0 |
| K933098 | MEDICAL IMAGE MANAGEMENT SYSTEM/X-RAY TERMINAL | Siemens Medical Solutions Health Services Corporat | 1993-09-20 | 88 | 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