Ge Medical Systems, LLC: FDA filings under this applicant name
FDA lists 105 510(k) clearances under the applicant name “Ge Medical Systems, LLC” (first 2003, latest 2026), across 17 product codes in 1 review panel. Median 510(k) review time under this name: 81 days. Since 2017 the median was 107 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 | 6 | 92 |
| 2013 | 4 | 124 |
| 2014 | 10 | 114 |
| 2015 | 3 | 85 |
| 2016 | 6 | 73 |
| 2017 | 4 | 98 |
| 2018 | 3 | 52 |
| 2019 | 5 | 90 |
| 2020 | 2 | 144 |
| 2021 | 6 | 47 |
| 2022 | 2 | 58 |
| 2023 | 3 | 113 |
| 2024 | 2 | 150 |
| 2025 | 5 | 128 |
| 2026 | 5 | 128 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ge Medical Systems, LLC took a median 107 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 |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 37 | 37 |
| JAK | System, X-Ray, Tomography, Computed | 30 | 30 |
| KPS | System, Tomography, Computed, Emission | 8 | 8 |
| IZL | System, X-Ray, Mobile | 6 | 6 |
| LLZ | System, Image Processing, Radiological | 5 | 5 |
| OUO | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | 3 | 3 |
| OWB | Interventional Fluoroscopic X-Ray System | 3 | 3 |
| MOS | Coil, Magnetic Resonance, Specialty | 2 | 2 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | 2 |
| QIH | Automated Radiological Image Processing Software | 2 | 2 |
Plus 7 more product codes.
Review panels
- Radiology (105)
Most recent Ge Medical Systems, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253560 | Enhanced Boundary for PCCT | JAK | 2026-06-24 | 219 |
| K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorithm | QIH | 2026-04-14 | 166 |
| K253520 | Photonova Spectra, Photonova Spectra Select | JAK | 2026-03-20 | 128 |
| K253780 | SIGNA Bolt | LNH | 2026-02-06 | 72 |
| K253779 | SIGNA Sprint Select | LNH | 2026-02-05 | 71 |
| K252379 | AIR Recon DL | LNH | 2025-12-23 | 146 |
| K251399 | SIGNA Sprint | LNH | 2025-09-11 | 128 |
| K250941 | Revolution Vibe | JAK | 2025-08-01 | 126 |
| K243667 | Sonic DL | LNH | 2025-06-05 | 190 |
| K250379 | SIGNA Prime Elite | LNH | 2025-03-17 | 34 |
95 earlier clearances. See the full list in Caduvo.
Recalls
235 product recalls in 77 recall events; 124 initiated in the last five years. Most recent: 2026-06-05.
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 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 MOS)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ge Medical Systems, LLC?
FDA lists 105 510(k) clearances under the applicant name “Ge Medical Systems, LLC” (first 2003, latest 2026), across 17 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 Medical Systems, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ge Medical Systems, LLC is 81 days. Since 2017: 107 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ge Medical Systems, LLC?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 37); JAK (System, X-Ray, Tomography, Computed, 30); KPS (System, Tomography, Computed, Emission, 8).
Next steps
- See all 105 Ge Medical Systems, LLC clearances with predicates and recalls
- Run predicate analysis for product code LNH, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.