Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Digimed 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) |
|---|---|---|---|---|---|
| K221587 | DHX-70H, XTG-70H | Digimed Co., Ltd. | 2023-03-03 | 275 | 0 |
| K220579 | Hybrid C70 | Digimed Co., Ltd. | 2022-09-01 | 192 | 0 |
| K220574 | HYBRID S70 | Digimed Co., Ltd. | 2022-04-22 | 53 | 0 |
| K181891 | Portable X-ray System (Model: MiniX-V, Mini X-S) | Digimed Co., Ltd. | 2018-08-10 | 28 | 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