Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rcadia Medical Imaging , 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) |
|---|---|---|---|---|---|
| K110071 | COR ANALYZER | Rcadia Medical Imaging , Ltd. | 2011-01-31 | 21 | 0 |
| K072242 | COR ANALYZER II, MODEL V1.7 | Rcadia Medical Imaging , Ltd. | 2007-09-11 | 29 | 0 |
| K063548 | COR ANALYZER 1, VERSION 1.4 | Rcadia Medical Imaging , Ltd. | 2007-01-22 | 59 | 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