Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ge Healthcare Japan Corporation · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
322 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253686 | True Definition DL | Ge Healthcare Japan Corporation | 2026-03-23 | 122 | 0 |
| K233698 | True Enhance DL | Ge Healthcare Japan Corporation | 2024-04-11 | 146 | 0 |
| K230807 | Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation | 2023-04-20 | 28 | 0 |
| K220961 | Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation | 2022-07-29 | 119 | 0 |
| K213938 | Revolution Ascend | Ge Healthcare Japan Corporation | 2022-02-04 | 50 | 2 |
| K212067 | Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation | 2021-09-17 | 77 | 0 |
| K203169 | Revolution Ascend | Ge Healthcare Japan Corporation | 2020-11-20 | 28 | 0 |
| K193170 | Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation | 2019-12-13 | 28 | 0 |
| K143345 | SIGNA Pioneer | Ge Healthcare Japan Corporation | 2015-07-10 | 231 | 4 |
| K103327 | DISCOVERY MR750W 3.0T | Ge Healthcare Japan Corporation | 2011-09-30 | 322 | 4 |
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