Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ge Oec Medical Systems · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
137 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K073543 | OEC 9900 ELITE | Ge Oec Medical Systems | 2008-05-02 | 137 | 5 |
| K061953 | 9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION O | Ge Oec Medical Systems | 2006-08-15 | 36 | 1 |
| K052039 | GE OEC ALTITUDE | Ge Oec Medical Systems | 2005-08-11 | 14 | 0 |
| K024012 | OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM | Ge Oec Medical Systems | 2003-03-20 | 106 | 20 |
| K022069 | OEC FLUOROTRAK 9800 PLUS | Ge Oec Medical Systems | 2002-09-17 | 84 | 17 |
| K021049 | OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM | Ge Oec Medical Systems | 2002-04-17 | 16 | 25 |
| K003837 | FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM | Ge Oec Medical Systems | 2001-03-12 | 90 | 9 |
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