GE Healthcare: FDA clearances and approvals
GE Healthcare has 169 FDA 510(k) clearances (first 2004, latest 2026), plus 3 PMA decisions, across 37 product codes in 7 review panels. Median 510(k) review time: 56 days. Since 2017 its median was 82 days, against 126 days for all cleared 510(k)s in the same product codes. openFDA lists 793 product recalls by a recalling firm named GE Healthcare. It is the industry lead sponsor of 52 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 12 | 36 |
| 2013 | 9 | 81 |
| 2014 | 8 | 32 |
| 2015 | 8 | 78 |
| 2016 | 13 | 58 |
| 2017 | 7 | 58 |
| 2018 | 11 | 79 |
| 2019 | 4 | 104 |
| 2020 | 4 | 134 |
| 2021 | 8 | 64 |
| 2022 | 3 | 63 |
| 2023 | 3 | 192 |
| 2024 | 1 | 54 |
| 2025 | 1 | 189 |
| 2026 | 1 | 50 |
Review time against the same product codes
Since 2017, GE Healthcare's cleared 510(k)s took a median 82 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 52 | 52 |
| LLZ | System, Image Processing, Radiological | 23 | 23 |
| KPS | System, Tomography, Computed, Emission | 12 | 12 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 10 | 10 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 10 | 9 |
| JAK | System, X-Ray, Tomography, Computed | 7 | 7 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 5 | 5 |
| MSX | System, Network And Communication, Physiological Monitors | 5 | 5 |
| OWB | Interventional Fluoroscopic X-Ray System | 5 | 5 |
| DQK | Computer, Diagnostic, Programmable | 4 | 4 |
Plus 27 more product codes.
Review panels
- Radiology (128)
- Cardiovascular (24)
- Neurology (7)
- Anesthesiology (6)
- General Hospital (5)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
Most recent GE Healthcare 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253639 | View | LLZ | 2026-01-08 | 50 |
| K242925 | MR Contour DL | QKB | 2025-04-01 | 189 |
| K241300 | ViewPoint 6 | LLZ | 2024-07-02 | 54 |
| K232346 | Digital Expert Access with Remote Scanning | LNH | 2023-10-27 | 84 |
| K223212 | Precision DL | KPS | 2023-04-27 | 192 |
| K221680 | Xeleris V Processing and Review System | LLZ | 2023-03-01 | 265 |
| K221932 | Omni Legend | KPS | 2022-09-02 | 63 |
| K213689 | Voluson P6, Voluson P8 | IYN | 2022-02-17 | 86 |
| K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert | IYN | 2022-01-13 | 56 |
| K211488 | LOGIQ E10 | IYN | 2021-09-10 | 120 |
159 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P130020 | PMA | SENOCLAIRE | 2014-08-26 |
| P110006 | PMA | SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM) | 2012-09-18 |
| P990066 | PMA | GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | 2000-01-28 |
Recalls
793 product recalls in 384 recall events; 92 initiated in the last five years. Most recent: 2026-07-31.
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.
Device clinical trials
GE Healthcare is the industry lead sponsor of 52 device studies on ClinicalTrials.gov (5 active or recruiting). Most recent:
- NCT06702917: GSI Cardiac on Revolution Apex - US (Recruiting, started 2025-09-10)
- NCT07046234: Point of Care Lung Ultrasound Examination in Patients With Shortness of Breath (Enrolling by invitation, started 2025-08-19)
- NCT06769594: Next Generation CT System (Completed, started 2025-04-08)
- NCT06835647: Maternal Fetal Device Performance Twins (Recruiting, started 2025-01-21)
- NCT06726343: Maternal Fetal Device Performance Singleton (Completed, started 2024-10-28)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of GE Healthcare'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 MOS)
Frequently asked questions
How many FDA 510(k) clearances does GE Healthcare have?
GE Healthcare has 169 FDA 510(k) clearances (first 2004, latest 2026), plus 3 PMA decisions, across 37 product codes in 7 review panels.
How long does FDA take to clear GE Healthcare's 510(k)s?
The median time from FDA receipt to decision across GE Healthcare's cleared 510(k)s is 56 days. Since 2017: 82 days, versus 126 days for all cleared 510(k)s in the same product codes.
What devices does GE Healthcare make?
Its most frequent FDA product codes are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 52); LLZ (System, Image Processing, Radiological, 23); KPS (System, Tomography, Computed, Emission, 12).
Has GE Healthcare had device recalls?
openFDA lists 793 product recalls in 384 recall events by a recalling firm whose name matches GE Healthcare; the most recent began 2026-07-31. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 169 GE Healthcare clearances with predicates and recalls
- Run predicate analysis for product code IYN, GE Healthcare'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.