Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ge Healthcare (Tianjin) Company Limited · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
205 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233728 | SIGNA Champion | Ge Healthcare (Tianjin) Company Limited | 2024-01-19 | 59 | 0 |
| K223439 | SIGNA Victor | Ge Healthcare (Tianjin) Company Limited | 2023-02-13 | 91 | 1 |
| K213603 | SIGNA Artist Evo | Ge Healthcare (Tianjin) Company Limited | 2022-02-11 | 88 | 1 |
| K211980 | SIGNA Prime | Ge Healthcare (Tianjin) Company Limited | 2022-01-16 | 205 | 2 |
| K202238 | SIGNA Artist | Ge Healthcare (Tianjin) Company Limited | 2020-09-04 | 28 | 4 |
| K192426 | Signa Voyager, Signa Voyager Quantum | Ge Healthcare (Tianjin) Company Limited | 2019-10-01 | 26 | 3 |
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