Ge Healthcare (Ge Medical Systems, LLC): FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ge Healthcare (Ge Medical Systems, LLC)” (first 2013, latest 2022), across 1 product code in 1 review panel. Median 510(k) review time under this name: 96 days. Since 2017 the median was 59 days, against 101 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 |
|---|---|---|
| 2013 | 2 | 113 |
| 2014 | 0 | — |
| 2015 | 1 | 84 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 90 |
| 2021 | 0 | — |
| 2022 | 1 | 59 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ge Healthcare (Ge Medical Systems, LLC) took a median 59 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 6 | 6 |
Review panels
- Radiology (6)
Most recent Ge Healthcare (Ge Medical Systems, LLC) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213668 | SIGNA Hero | LNH | 2022-01-20 | 59 |
| K202966 | SIGNA Architect | LNH | 2020-11-13 | 44 |
| K193282 | SIGNA Premier | LNH | 2020-04-10 | 135 |
| K143251 | SIGNA Creator, SIGNA Explorer | LNH | 2015-02-04 | 84 |
| K132376 | DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T | LNH | 2013-11-15 | 108 |
| K123522 | OPTIMA MR450W | LNH | 2013-03-13 | 118 |
Recalls
openFDA lists no recalls under a recalling firm named Ge Healthcare (Ge Medical Systems, LLC).
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 Healthcare (Ge Medical Systems, LLC) (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 are listed under Ge Healthcare (Ge Medical Systems, LLC)?
FDA lists 6 510(k) clearances under the applicant name “Ge Healthcare (Ge Medical Systems, LLC)” (first 2013, latest 2022), across 1 product code 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 Healthcare (Ge Medical Systems, LLC)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ge Healthcare (Ge Medical Systems, LLC) is 96 days. Since 2017: 59 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ge Healthcare (Ge Medical Systems, LLC)?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 6).
Next steps
- See all 6 Ge Healthcare (Ge Medical Systems, LLC) clearances with predicates and recalls
- Run predicate analysis for product code LNH, Ge Healthcare (Ge Medical Systems, LLC)'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.