Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Radiomed Corporation · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
310 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161724 | Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Lo | Radiomed Corporation | 2017-04-28 | 310 | 0 |
| K120859 | PRE-LOADED GOLD VISICOIL CK MARKER | Radiomed Corporation | 2012-04-19 | 28 | 0 |
| K070305 | PRE-LOADED VISICOIL | Radiomed Corporation | 2007-03-07 | 34 | 0 |
| K022326 | RADIOMED MARKER | Radiomed Corporation | 2003-01-31 | 197 | 0 |
| K013660 | GENETRA | Radiomed Corporation | 2001-12-05 | 29 | 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