Ge Healthcare Japan Corporation: FDA clearances and approvals
Ge Healthcare Japan Corporation has 10 FDA 510(k) clearances (first 2011, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time: 98 days. Since 2017 its median was 64 days, against 116 days for all cleared 510(k)s in the same product codes. openFDA lists 4 product recalls by a recalling firm named Ge Healthcare Japan Corporation.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 231 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 28 |
| 2020 | 1 | 28 |
| 2021 | 1 | 77 |
| 2022 | 2 | 84 |
| 2023 | 1 | 28 |
| 2024 | 1 | 146 |
| 2025 | 0 | — |
| 2026 | 1 | 122 |
Review time against the same product codes
Since 2017, Ge Healthcare Japan Corporation's cleared 510(k)s took a median 64 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 8 | 8 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 2 | 2 |
Review panels
- Radiology (10)
Most recent Ge Healthcare Japan Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253686 | True Definition DL | JAK | 2026-03-23 | 122 |
| K233698 | True Enhance DL | JAK | 2024-04-11 | 146 |
| K230807 | Deep Learning Image Reconstruction | JAK | 2023-04-20 | 28 |
| K220961 | Deep Learning Image Reconstruction | JAK | 2022-07-29 | 119 |
| K213938 | Revolution Ascend | JAK | 2022-02-04 | 50 |
| K212067 | Deep Learning Image Reconstruction | JAK | 2021-09-17 | 77 |
| K203169 | Revolution Ascend | JAK | 2020-11-20 | 28 |
| K193170 | Deep Learning Image Reconstruction | JAK | 2019-12-13 | 28 |
| K143345 | SIGNA Pioneer | LNH | 2015-07-10 | 231 |
| K103327 | DISCOVERY MR750W 3.0T | LNH | 2011-09-30 | 322 |
Recalls
4 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2018-04-27.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Ge Healthcare Japan Corporation's product codes (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Frequently asked questions
How many FDA 510(k) clearances does Ge Healthcare Japan Corporation have?
Ge Healthcare Japan Corporation has 10 FDA 510(k) clearances (first 2011, latest 2026), across 2 product codes in 1 review panel.
How long does FDA take to clear Ge Healthcare Japan Corporation's 510(k)s?
The median time from FDA receipt to decision across Ge Healthcare Japan Corporation's cleared 510(k)s is 98 days. Since 2017: 64 days, versus 116 days for all cleared 510(k)s in the same product codes.
What devices does Ge Healthcare Japan Corporation make?
Its most frequent FDA product codes are JAK (System, X-Ray, Tomography, Computed, 8); LNH (System, Nuclear Magnetic Resonance Imaging, 2).
Has Ge Healthcare Japan Corporation had device recalls?
openFDA lists 4 product recalls in 1 recall event by a recalling firm whose name matches Ge Healthcare Japan Corporation; the most recent began 2018-04-27. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 10 Ge Healthcare Japan Corporation clearances with predicates and recalls
- Run predicate analysis for product code JAK, Ge Healthcare Japan Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.