Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Candelis, Inc. — 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) |
|---|---|---|---|---|---|
| K262143 | ImageGrid StreamVue | Candelis, Inc. | 2026-07-23 | 28 | 0 |
| K111694 | ASTRA | Candelis, Inc. | 2011-09-15 | 91 | 0 |
| K092949 | IMAGEGRID RADIOLOGY VIEWER SYSTEM | Candelis, Inc. | 2009-10-08 | 14 | 0 |
| K080333 | IMAGEGRID | Candelis, Inc. | 2008-02-22 | 15 | 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