Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ge Medical System Israel , 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) |
|---|---|---|---|---|---|
| K121063 | VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC U | Ge Medical System Israel , Ltd. | 2012-08-21 | 137 | 2 |
| K121062 | VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULT | Ge Medical System Israel , Ltd. | 2012-08-17 | 133 | 1 |
| K102393 | VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICUL | Ge Medical System Israel , Ltd. | 2010-11-05 | 74 | 2 |
| K102388 | VIVID I DIAGNOSTIC ULTRASOUND SYSTEM | Ge Medical System Israel , Ltd. | 2010-11-04 | 73 | 2 |
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