Ge Vingmed Ultrasound AS: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Ge Vingmed Ultrasound AS” (first 2009, latest 2015), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 47 days. 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 |
|---|---|---|
| 2012 | 1 | 87 |
| 2013 | 3 | 45 |
| 2014 | 1 | 17 |
| 2015 | 2 | 47 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 4 | 4 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
Review panels
- Radiology (10)
Most recent Ge Vingmed Ultrasound AS 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150087 | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System | IYN | 2015-03-04 | 48 |
| K150085 | GE EchoPAC | LLZ | 2015-03-02 | 46 |
| K141093 | 6VT-D ULTRASOUND TRANSDUCER | ITX | 2014-05-15 | 17 |
| K131685 | GE ECHOPAC | LLZ | 2013-09-24 | 106 |
| K131514 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | IYN | 2013-07-12 | 45 |
| K123894 | GE ECHOPAC | LLZ | 2013-01-29 | 42 |
| K120201 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | IYO | 2012-04-19 | 87 |
| K101149 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | IYO | 2010-10-13 | 173 |
| K101324 | GE ECHOPAC MODEL BT10 | LLZ | 2010-10-05 | 147 |
| K092756 | GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM | ITX | 2009-09-28 | 19 |
Recalls
6 product recalls in 2 recall events; 6 initiated in the last five years. Most recent: 2024-05-02.
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 Vingmed Ultrasound AS?
FDA lists 10 510(k) clearances under the applicant name “Ge Vingmed Ultrasound AS” (first 2009, latest 2015), 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 Vingmed Ultrasound AS?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ge Vingmed Ultrasound AS is 47 days.
Which FDA product codes appear under Ge Vingmed Ultrasound AS?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 4); ITX (Transducer, Ultrasonic, Diagnostic, 2); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 2).
Next steps
- See all 10 Ge Vingmed Ultrasound AS clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Ge Vingmed Ultrasound AS'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.