Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mrc Systems GmbH — 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) |
|---|---|---|---|---|---|
| K030609 | MODULEAF | Mrc Systems GmbH | 2003-03-17 | 19 | 1 |
| K022307 | KONRAD, MODEL V.2.0 | Mrc Systems GmbH | 2002-10-08 | 84 | 1 |
| K011816 | MINI MULTILEAF COLLIMATOR, MODEL KMI | Mrc Systems GmbH | 2001-09-07 | 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