Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
C4 Imaging, LLC — 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) |
|---|---|---|---|---|---|
| K192771 | C4 Fiducial Marker | C4 Imaging, LLC | 2020-10-21 | 387 | 0 |
| K180069 | HDR MRI Lumen Marker | C4 Imaging, LLC | 2018-04-27 | 108 | 0 |
| K171487 | Sirius MRI Marker NS | C4 Imaging, LLC | 2017-08-25 | 95 | 0 |
| K131689 | MRI MARKER | C4 Imaging, LLC | 2013-11-20 | 163 | 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