Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ge Medical Systems Israel, Functional Imaging — 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) |
|---|---|---|---|---|---|
| K243605 | Aurora | Ge Medical Systems Israel, Functional Imaging | 2025-01-17 | 57 | 0 |
| K241350 | Clarify DL | Ge Medical Systems Israel, Functional Imaging | 2025-01-03 | 235 | 0 |
| K241665 | Omni Legend | Ge Medical Systems Israel, Functional Imaging | 2024-08-08 | 59 | 1 |
| K102231 | DISCOVERY NM 750B | Ge Medical Systems Israel, Functional Imaging | 2010-11-03 | 86 | 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