Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Careray Digital Medical Technology Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232058 | YosemiteView 4343W/YosemiteView 3643W | Careray Digital Medical Technology Co., Ltd. | 2023-08-03 | 23 | 0 |
| K223687 | X-ray Flat Panel Detectors (EverestView 4343X) | Careray Digital Medical Technology Co., Ltd. | 2022-12-30 | 21 | 0 |
| K221549 | X-ray Flat Panel Detectors (CareView 1800 RF) | Careray Digital Medical Technology Co., Ltd. | 2022-08-01 | 62 | 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