Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ge Hangwei Medical Systems Co., Ltd. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
153 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233749 | Revolution Ascend Sliding | Ge Hangwei Medical Systems Co., Ltd. | 2024-02-22 | 92 | 0 |
| K192956 | Auto Positioning | Ge Hangwei Medical Systems Co., Ltd. | 2020-01-16 | 87 | 0 |
| K192686 | Revolution Maxima, Revolution Ace | Ge Hangwei Medical Systems Co., Ltd. | 2019-10-24 | 28 | 5 |
| K171013 | Revolution ACT | Ge Hangwei Medical Systems Co., Ltd. | 2017-06-05 | 62 | 0 |
| K160131 | OEC Elite MiniView | Ge Hangwei Medical Systems Co., Ltd. | 2016-06-21 | 153 | 0 |
| K123596 | OPTIMA CT520 | Ge Hangwei Medical Systems Co., Ltd. | 2013-02-08 | 79 | 3 |
| K123417 | BRIVO MR355, OPTIMA MR360 | Ge Hangwei Medical Systems Co., Ltd. | 2013-01-17 | 72 | 5 |
| K122694 | GE 8CH FOOT ANKLE COIL | Ge Hangwei Medical Systems Co., Ltd. | 2012-10-25 | 51 | 0 |
| K120778 | BRIVO MR355 | Ge Hangwei Medical Systems Co., Ltd. | 2012-03-27 | 13 | 3 |
| K103330 | BRIVO MR355, OPTIMA MR360 | Ge Hangwei Medical Systems Co., Ltd. | 2011-02-11 | 91 | 5 |
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