Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ge Healthcare (Ge Medical Systems, LLC) · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
135 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213668 | SIGNA Hero | Ge Healthcare (Ge Medical Systems, LLC) | 2022-01-20 | 59 | 2 |
| K202966 | SIGNA Architect | Ge Healthcare (Ge Medical Systems, LLC) | 2020-11-13 | 44 | 7 |
| K193282 | SIGNA Premier | Ge Healthcare (Ge Medical Systems, LLC) | 2020-04-10 | 135 | 5 |
| K143251 | SIGNA Creator, SIGNA Explorer | Ge Healthcare (Ge Medical Systems, LLC) | 2015-02-04 | 84 | 11 |
| K132376 | DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W | Ge Healthcare (Ge Medical Systems, LLC) | 2013-11-15 | 108 | 10 |
| K123522 | OPTIMA MR450W | Ge Healthcare (Ge Medical Systems, LLC) | 2013-03-13 | 118 | 1 |
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