Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neusoft Digital Medical Systems 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) |
|---|---|---|---|---|---|
| K041542 | CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNE | Neusoft Digital Medical Systems Co., Ltd. | 2004-06-17 | 9 | 0 |
| K033315 | SUPEROPEN 0.23T, MODEL NAM-P023A | Neusoft Digital Medical Systems Co., Ltd. | 2003-10-29 | 14 | 0 |
| K030918 | SUPEROPEN 0.35T, MODEL NSM-P035 | Neusoft Digital Medical Systems Co., Ltd. | 2003-04-01 | 8 | 0 |
| K020913 | CT-C3000 SPIRAL CT SCANNER SYSTEM | Neusoft Digital Medical Systems Co., Ltd. | 2002-04-03 | 13 | 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