Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ge Medical Systems Israel, Ultrasound, Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092140 | GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTR | Ge Medical Systems Israel, Ultrasound, Ltd. | 2009-08-21 | 37 | 2 |
| K092079 | MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND | Ge Medical Systems Israel, Ultrasound, Ltd. | 2009-08-06 | 28 | 2 |
| K082374 | VIVID I AND VIVID Q | Ge Medical Systems Israel, Ultrasound, Ltd. | 2008-09-02 | 15 | 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