Ge Hangwei Medical Systems Co., Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Ge Hangwei Medical Systems Co., Ltd.” (first 2011, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 76 days. Since 2017 the median was 74 days, against 112 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under GE HealthCare, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 32 |
| 2013 | 2 | 76 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 153 |
| 2017 | 1 | 62 |
| 2018 | 0 | — |
| 2019 | 1 | 28 |
| 2020 | 1 | 87 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 92 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ge Hangwei Medical Systems Co., Ltd. took a median 74 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 5 | 5 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 3 | 3 |
| MOS | Coil, Magnetic Resonance, Specialty | 1 | 1 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 1 | 1 |
Review panels
- Radiology (10)
Most recent Ge Hangwei Medical Systems Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233749 | Revolution Ascend Sliding | JAK | 2024-02-22 | 92 |
| K192956 | Auto Positioning | JAK | 2020-01-16 | 87 |
| K192686 | Revolution Maxima, Revolution Ace | JAK | 2019-10-24 | 28 |
| K171013 | Revolution ACT | JAK | 2017-06-05 | 62 |
| K160131 | OEC Elite MiniView | OXO | 2016-06-21 | 153 |
| K123596 | OPTIMA CT520 | JAK | 2013-02-08 | 79 |
| K123417 | BRIVO MR355, OPTIMA MR360 | LNH | 2013-01-17 | 72 |
| K122694 | GE 8CH FOOT ANKLE COIL | MOS | 2012-10-25 | 51 |
| K120778 | BRIVO MR355 | LNH | 2012-03-27 | 13 |
| K103330 | BRIVO MR355, OPTIMA MR360 | LNH | 2011-02-11 | 91 |
Recalls
2 product recalls in 1 recall events; 2 initiated in the last five years. Most recent: 2023-11-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Ge Hangwei Medical Systems Co., Ltd. (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 MOS)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ge Hangwei Medical Systems Co., Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Ge Hangwei Medical Systems Co., Ltd.” (first 2011, latest 2024), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ge Hangwei Medical Systems Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ge Hangwei Medical Systems Co., Ltd. is 76 days. Since 2017: 74 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ge Hangwei Medical Systems Co., Ltd.?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 5); LNH (System, Nuclear Magnetic Resonance Imaging, 3); MOS (Coil, Magnetic Resonance, Specialty, 1).
Next steps
- See all 10 Ge Hangwei Medical Systems Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JAK, Ge Hangwei Medical Systems Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.