Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
General Electric Medical Systems · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
15 daysmedian FDA review time
60 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052897 | GE DEFINIUM AMX 700, MODEL AMX 700 | General Electric Medical Systems | 2005-11-08 | 25 | 1 |
| K041521 | VOLUME VIEWER PLUS | General Electric Medical Systems | 2004-06-22 | 14 | 2 |
| K041270 | CT COLONOGRAPHY II | General Electric Medical Systems | 2004-05-27 | 15 | 0 |
| K041267 | CARDIQ ANALYSIS III | General Electric Medical Systems | 2004-05-27 | 15 | 0 |
| K021780 | ADVANTAGE SIM 6.0 | General Electric Medical Systems | 2002-07-29 | 60 | 1 |
| K014058 | ENTEGRA PE PERSONAL DIGITAL ASSISTANT | General Electric Medical Systems | 2001-12-21 | 11 | 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