GE Medical Systems SCS: FDA clearances and approvals
GE Medical Systems SCS has 38 FDA 510(k) clearances (first 2008, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time: 117 days. Since 2017 its median was 135 days, against 120 days for all cleared 510(k)s in the same product codes. openFDA lists 13 product recalls by a recalling firm named GE Medical Systems SCS.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 84 |
| 2013 | 1 | 93 |
| 2014 | 2 | 164 |
| 2015 | 0 | — |
| 2016 | 2 | 142 |
| 2017 | 0 | — |
| 2018 | 1 | 88 |
| 2019 | 2 | 135 |
| 2020 | 5 | 176 |
| 2021 | 3 | 219 |
| 2022 | 4 | 82 |
| 2023 | 3 | 120 |
| 2024 | 2 | 160 |
| 2025 | 4 | 174 |
| 2026 | 2 | 154 |
Review time against the same product codes
Since 2017, GE Medical Systems SCS's cleared 510(k)s took a median 135 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 16 | 16 |
| LLZ | System, Image Processing, Radiological | 12 | 12 |
| OWB | Interventional Fluoroscopic X-Ray System | 5 | 5 |
| KPS | System, Tomography, Computed, Emission | 3 | 3 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 2 | 2 |
Review panels
- Radiology (38)
Most recent GE Medical Systems SCS 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253770 | CardIQ Suite | JAK | 2026-07-21 | 237 |
| K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | MUE | 2026-03-24 | 71 |
| K251199 | Allia Moveo | OWB | 2025-12-09 | 235 |
| K243672 | CardIQ Suite | JAK | 2025-06-18 | 203 |
| K243651 | VersaViewer | LLZ | 2025-04-21 | 146 |
| K243446 | 3DXR | OWB | 2025-02-25 | 111 |
| K233731 | CardIQ Suite | JAK | 2024-08-01 | 254 |
| K233714 | BreView | LLZ | 2024-01-25 | 66 |
| K232344 | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR | OWB | 2023-10-11 | 68 |
| K223424 | Spine Auto Views | JAK | 2023-07-13 | 241 |
28 earlier clearances. See the full list in Caduvo.
Recalls
13 product recalls in 5 recall events; 10 initiated in the last five years. Most recent: 2026-05-08.
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.
Frequently asked questions
How many FDA 510(k) clearances does GE Medical Systems SCS have?
GE Medical Systems SCS has 38 FDA 510(k) clearances (first 2008, latest 2026), across 5 product codes in 1 review panel.
How long does FDA take to clear GE Medical Systems SCS's 510(k)s?
The median time from FDA receipt to decision across GE Medical Systems SCS's cleared 510(k)s is 117 days. Since 2017: 135 days, versus 120 days for all cleared 510(k)s in the same product codes.
What devices does GE Medical Systems SCS make?
Its most frequent FDA product codes are JAK (System, X-Ray, Tomography, Computed, 16); LLZ (System, Image Processing, Radiological, 12); OWB (Interventional Fluoroscopic X-Ray System, 5).
Has GE Medical Systems SCS had device recalls?
openFDA lists 13 product recalls in 5 recall events by a recalling firm whose name matches GE Medical Systems SCS; the most recent began 2026-05-08. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 38 GE Medical Systems SCS clearances with predicates and recalls
- Run predicate analysis for product code JAK, GE Medical Systems SCS'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.