Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shanghai United Imaging Intelligence 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) |
|---|---|---|---|---|---|
| K242292 | uAI Easy Triage ICH | Shanghai United Imaging Intelligence Co., Ltd. | 2024-09-24 | 53 | 0 |
| K240411 | uAI Portal | Shanghai United Imaging Intelligence Co., Ltd. | 2024-09-06 | 207 | 0 |
| K222755 | uMR 680 | Shanghai United Imaging Intelligence Co., Ltd. | 2023-02-16 | 157 | 0 |
| K193271 | uAI EasyTriage-Rib | Shanghai United Imaging Intelligence Co., Ltd. | 2021-01-15 | 416 | 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