Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Asg Superconductors S.P.A. · 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) |
|---|---|---|---|---|---|
| K242258 | MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) | Asg Superconductors S.P.A. | 2024-11-26 | 118 | 0 |
| K193116 | MRopen EVO | Asg Superconductors S.P.A. | 2019-12-20 | 38 | 0 |
| K192690 | Upgrade Kit MR GUI PRO, MrJ 3300 Plus | Asg Superconductors S.P.A. | 2019-10-24 | 28 | 0 |
| K190524 | MRopen 0.5 T | Asg Superconductors S.P.A. | 2019-07-01 | 119 | 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