Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Ge Medical Systems Ultrasound And · Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

122 daysmedian FDA review time

175 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K220882	Vivid E80, Vivid E90, Vivid E95	Ge Medical Systems Ultrasound And	2022-07-22	119	0
K200708	Vivid iq	Ge Medical Systems Ultrasound And	2020-09-09	175	0
K200743	Vivid E80/ Vivid E90/ Vivid E95	Ge Medical Systems Ultrasound And	2020-07-23	122	0
K200138	Versana Premier	Ge Medical Systems Ultrasound And	2020-07-01	162	0
K192917	ViewPoint 6	Ge Medical Systems Ultrasound And	2020-01-06	83	1

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