Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Visia Imaging S.R.L. — 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) |
|---|---|---|---|---|---|
| K222933 | MYAH | Visia Imaging S.R.L. | 2023-06-29 | 276 | 0 |
| K211868 | MYAH | Visia Imaging S.R.L. | 2022-03-01 | 258 | 0 |
| K160327 | ALADDIN HW3.0 | Visia Imaging S.R.L. | 2016-10-05 | 243 | 0 |
| K131567 | ALADDIN | Visia Imaging S.R.L. | 2014-06-05 | 371 | 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