Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Televere Systems — 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) |
|---|---|---|---|---|---|
| K172124 | Televere Podiatry Digital Imaging System | Televere Systems | 2017-11-09 | 118 | 0 |
| K170975 | Televere Digital Imaging System | Televere Systems | 2017-05-01 | 28 | 0 |
| K082623 | VISIX IMAGING | Televere Systems | 2009-02-25 | 169 | 0 |
| K061035 | TIGERVIEW PROFESSIONAL | Televere Systems | 2006-06-05 | 52 | 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