Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ge Vingmed Ultrasound AS · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
173 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150087 | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Di | Ge Vingmed Ultrasound AS | 2015-03-04 | 48 | 1 |
| K150085 | GE EchoPAC | Ge Vingmed Ultrasound AS | 2015-03-02 | 46 | 0 |
| K141093 | 6VT-D ULTRASOUND TRANSDUCER | Ge Vingmed Ultrasound AS | 2014-05-15 | 17 | 0 |
| K131685 | GE ECHOPAC | Ge Vingmed Ultrasound AS | 2013-09-24 | 106 | 0 |
| K131514 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Ge Vingmed Ultrasound AS | 2013-07-12 | 45 | 1 |
| K123894 | GE ECHOPAC | Ge Vingmed Ultrasound AS | 2013-01-29 | 42 | 0 |
| K120201 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Ge Vingmed Ultrasound AS | 2012-04-19 | 87 | 1 |
| K101149 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Ge Vingmed Ultrasound AS | 2010-10-13 | 173 | 0 |
| K101324 | GE ECHOPAC MODEL BT10 | Ge Vingmed Ultrasound AS | 2010-10-05 | 147 | 0 |
| K092756 | GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM | Ge Vingmed Ultrasound AS | 2009-09-28 | 19 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda