GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC” (first 2016, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 92 days. Since 2017 the median was 92 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 |
|---|---|---|
| 2016 | 4 | 91 |
| 2017 | 2 | 93 |
| 2018 | 2 | 68 |
| 2019 | 1 | 146 |
| 2020 | 1 | 86 |
| 2021 | 1 | 29 |
| 2022 | 1 | 89 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 2 | 165 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC took a median 92 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 8 | 8 |
| KGI | Densitometer, Bone | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | 1 | 1 |
Review panels
- Radiology (14)
Most recent GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252718 | Lunar Astra | KGI | 2026-04-20 | 235 |
| K254161 | Automated Aortic Stenosis Software (AutoAS) | POK | 2026-03-27 | 95 |
| K221148 | Vivid iq | IYN | 2022-07-18 | 89 |
| K203677 | ViewPoint 6 | LLZ | 2021-01-15 | 29 |
| K200158 | LOGIQ E10 | IYN | 2020-04-17 | 86 |
| K191112 | GEHC DXA Bone Densitometers with enCORE version 18 | KGI | 2019-09-19 | 146 |
| K181934 | Vivid T8, Vivid T9 | IYN | 2018-11-06 | 110 |
| K180782 | Aria | KGI | 2018-04-20 | 25 |
| K170714 | Venue | IYN | 2017-06-21 | 104 |
| K170878 | Vivid S60N, Vivid S70N | IYN | 2017-06-14 | 82 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named GE Medical Systems Ultrasound & Primary Care Diagnostics, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC?
FDA lists 14 510(k) clearances under the applicant name “GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC” (first 2016, latest 2026), across 4 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 Ultrasound & Primary Care Diagnostics, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC is 92 days. Since 2017: 92 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 8); KGI (Densitometer, Bone, 4); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 14 GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC clearances with predicates and recalls
- Run predicate analysis for product code IYN, GE Medical Systems Ultrasound & Primary Care Diagnostics, 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.