Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Siemens Shenzhen Magnetic Resonance , Ltd. · 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) |
|---|---|---|---|---|---|
| K260265 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | 2026-02-23 | 26 | 0 |
| K251822 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. | 2025-11-20 | 160 | 0 |
| K250436 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance , Ltd. | 2025-06-16 | 122 | 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