Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
168 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252718 | Lunar Astra | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026-04-20 | 235 | 0 |
| K254161 | Automated Aortic Stenosis Software (AutoAS) | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2026-03-27 | 95 | 0 |
| K221148 | Vivid iq | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2022-07-18 | 89 | 0 |
| K203677 | ViewPoint 6 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2021-01-15 | 29 | 1 |
| K200158 | LOGIQ E10 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2020-04-17 | 86 | 0 |
| K191112 | GEHC DXA Bone Densitometers with enCORE version 18 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2019-09-19 | 146 | 1 |
| K181934 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2018-11-06 | 110 | 0 |
| K180782 | Aria | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2018-04-20 | 25 | 0 |
| K170714 | Venue | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2017-06-21 | 104 | 0 |
| K170878 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2017-06-14 | 82 | 2 |
| K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016-12-02 | 168 | 1 |
| K161588 | Vscan Extend | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016-08-31 | 84 | 7 |
| K161224 | LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016-08-05 | 98 | 0 |
| K153037 | LOGIQ V1/ LOGIQ V2 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016-01-04 | 77 | 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