Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ecotron Co., Ltd. — 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) |
|---|---|---|---|---|---|
| K221233 | DT-703 | Ecotron Co., Ltd. | 2022-06-27 | 59 | 0 |
| K180473 | ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240D | Ecotron Co., Ltd. | 2018-03-23 | 29 | 0 |
| K160279 | ANYVIEW-500R Fluoroscopic Mobile X-Ray System | Ecotron Co., Ltd. | 2016-10-14 | 255 | 0 |
| K151038 | EPX-Series Mobile X-ray System | Ecotron Co., Ltd. | 2015-07-24 | 95 | 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