Ge Medical Systems Ultrasound And: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Ge Medical Systems Ultrasound And” (first 2020, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 122 days. Since 2017 the median was 122 days, against 110 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 |
|---|---|---|
| 2020 | 4 | 142 |
| 2021 | 0 | — |
| 2022 | 1 | 119 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ge Medical Systems Ultrasound And took a median 122 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Radiology (5)
Most recent Ge Medical Systems Ultrasound And 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220882 | Vivid E80, Vivid E90, Vivid E95 | IYN | 2022-07-22 | 119 |
| K200708 | Vivid iq | IYN | 2020-09-09 | 175 |
| K200743 | Vivid E80/ Vivid E90/ Vivid E95 | IYN | 2020-07-23 | 122 |
| K200138 | Versana Premier | IYN | 2020-07-01 | 162 |
| K192917 | ViewPoint 6 | LLZ | 2020-01-06 | 83 |
Recalls
openFDA lists no recalls under a recalling firm named Ge Medical Systems Ultrasound And.
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 And?
FDA lists 5 510(k) clearances under the applicant name “Ge Medical Systems Ultrasound And” (first 2020, latest 2022), across 2 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 And?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ge Medical Systems Ultrasound And is 122 days. Since 2017: 122 days, versus 110 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ge Medical Systems Ultrasound And?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 4); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 5 Ge Medical Systems Ultrasound And clearances with predicates and recalls
- Run predicate analysis for product code IYN, Ge Medical Systems Ultrasound And'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.