GE Medical Systems: FDA clearances and approvals
GE Medical Systems has 329 FDA 510(k) clearances (first 1989, latest 2026), plus 1 PMA decision, across 41 product codes in 6 review panels. Median 510(k) review time: 71 days. Since 2017 its median was 96 days, against 113 days for all cleared 510(k)s in the same product codes. openFDA lists 235 product recalls by a recalling firm named GE Medical Systems.
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 | 5 | 88 |
| 2018 | 3 | 52 |
| 2019 | 5 | 90 |
| 2020 | 2 | 144 |
| 2021 | 6 | 47 |
| 2022 | 4 | 78 |
| 2023 | 3 | 113 |
| 2024 | 2 | 150 |
| 2025 | 5 | 128 |
| 2026 | 6 | 147 |
Review time against the same product codes
Since 2017, GE Medical Systems's cleared 510(k)s took a median 96 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 82 | 82 |
| JAK | System, X-Ray, Tomography, Computed | 68 | 68 |
| KPS | System, Tomography, Computed, Emission | 27 | 27 |
| LLZ | System, Image Processing, Radiological | 19 | 19 |
| MOS | Coil, Magnetic Resonance, Specialty | 19 | 19 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 12 | 12 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 11 | 11 |
| OWB | Interventional Fluoroscopic X-Ray System | 11 | 11 |
| IZI | System, X-Ray, Angiographic | 10 | 10 |
| KPR | System, X-Ray, Stationary | 9 | 9 |
Plus 31 more product codes.
Review panels
- Radiology (318)
- General Hospital (5)
- Cardiovascular (3)
- Obstetrics and Gynecology (2)
- Anesthesiology (1)
- General and Plastic Surgery (1)
Most recent GE Medical Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253808 | AIR Recon DL | LNH | 2026-08-13 | 258 |
| 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 |
319 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P870025 | PMA | FETAL ACOUSTIC STIMULATOR, MODEL 0146AAY | 1988-08-31 |
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 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 Medical Systems'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 LNI)
Frequently asked questions
How many FDA 510(k) clearances does GE Medical Systems have?
GE Medical Systems has 329 FDA 510(k) clearances (first 1989, latest 2026), plus 1 PMA decision, across 41 product codes in 6 review panels.
How long does FDA take to clear GE Medical Systems's 510(k)s?
The median time from FDA receipt to decision across GE Medical Systems's cleared 510(k)s is 71 days. Since 2017: 96 days, versus 113 days for all cleared 510(k)s in the same product codes.
What devices does GE Medical Systems make?
Its most frequent FDA product codes are LNH (System, Nuclear Magnetic Resonance Imaging, 82); JAK (System, X-Ray, Tomography, Computed, 68); KPS (System, Tomography, Computed, Emission, 27).
Has GE Medical Systems had device recalls?
openFDA lists 235 product recalls in 77 recall events by a recalling firm whose name matches GE Medical Systems; the most recent began 2026-06-05. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 329 GE Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code LNH, GE Medical Systems'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.