Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ge Oec Medical Systems, Inc. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
134 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233669 | OEC 3D | Ge Oec Medical Systems, Inc. | 2024-03-28 | 134 | 2 |
| K203346 | OEC 3D | Ge Oec Medical Systems, Inc. | 2021-03-05 | 112 | 2 |
| K192819 | OEC Elite | Ge Oec Medical Systems, Inc. | 2019-11-08 | 38 | 3 |
| K172550 | OEC Elite | Ge Oec Medical Systems, Inc. | 2017-11-16 | 85 | 3 |
| K171565 | OEC Elite | Ge Oec Medical Systems, Inc. | 2017-08-10 | 72 | 3 |
| K132027 | OEC 9800 PLUS | Ge Oec Medical Systems, Inc. | 2014-05-01 | 304 | 8 |
| K111551 | OEC(R) 9800, OEC(R) 9800 PLUS | Ge Oec Medical Systems, Inc. | 2011-10-04 | 123 | 8 |
| K051490 | GE OEC EVERVIEW 7500 | Ge Oec Medical Systems, Inc. | 2005-07-07 | 31 | 0 |
| K043076 | GE OEC FLUOROSTAR | Ge Oec Medical Systems, Inc. | 2004-12-22 | 44 | 1 |
| K041931 | OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGA | Ge Oec Medical Systems, Inc. | 2004-08-26 | 38 | 5 |
| K041932 | OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM | Ge Oec Medical Systems, Inc. | 2004-08-18 | 30 | 7 |
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