Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ge Dec Medical Systems — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
213 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000221 | SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT | Ge Dec Medical Systems | 2000-04-11 | 78 | 1 |
| K993687 | UROVIEW 2800 | Ge Dec Medical Systems | 1999-12-21 | 50 | 11 |
| K992506 | MINI 6800 DIGITAL MOBILE C-ARM | Ge Dec Medical Systems | 1999-08-19 | 23 | 7 |
| K974355 | INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED | Ge Dec Medical Systems | 1998-02-17 | 90 | 0 |
| K970063 | SERIES 7600 MOBILE DIGITAL C-ARM | Ge Dec Medical Systems | 1997-03-11 | 63 | 1 |
| K963952 | SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM | Ge Dec Medical Systems | 1996-12-23 | 82 | 1 |
| K950781 | COMPACT 7600 | Ge Dec Medical Systems | 1995-06-05 | 104 | 0 |
| K951765 | SERIES 6600 DIGITAL MOBILE C-ARM | Ge Dec Medical Systems | 1995-05-11 | 24 | 0 |
| K940295 | UROVIEW MODEL 2600 | Ge Dec Medical Systems | 1994-08-22 | 213 | 1 |
| K936136 | UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE | Ge Dec Medical Systems | 1994-01-25 | 34 | 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