Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

GE Medical Systems Ultrasound and Primary Care Diagnostics

FDA 510(k) & PMA Approved Devices — 63 products

Total Devices63
Categories4
Latest FDA decision2026-07-30
TypeNumberDevice NameCodeDateActions
510(k) K261835 LOGIQ FocusIYN2026-07-30 View
510(k) K260398 LOGIQ eIYN2026-05-26 View
510(k) K260673 LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 PowerIYN2026-03-24 View
510(k) K253370 LOGIQ TotusIYN2026-01-08 View
510(k) K253366 LOGIQ FortisIYN2026-01-07 View
510(k) K252328 Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2025-11-24 View
510(k) K251985 LOGIQ E10IYN2025-10-29 View
510(k) K251963 LOGIQ E10sIYN2025-10-29 View
510(k) K251322 Venue; Venue Go; Venue Fit; Venue SprintIYN2025-07-25 View
510(k) K251342 EchoPAC Software Only / EchoPAC Plug-inQIH2025-07-16 View
510(k) K251169 Vivid PioneerIYN2025-07-10 View
510(k) K250543 Voluson™ Performance 16; Voluson™ Performance 18IYN2025-05-29 View
510(k) K250087 Vscan AirIYN2025-05-01 View
510(k) K243620 Vivid iqIYN2025-02-11 View
510(k) K243628 Vivid T9/Vivid T8IYN2025-02-11 View
510(k) K242168 Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2024-12-20 View
510(k) K242005 Versana Premier; Versana Premier Lotus; LOGIQ FIYN2024-10-02 View
510(k) K240053 Venue GoIYN2024-06-10 View
510(k) K240206 Venue SprintIYN2024-06-10 View
510(k) K234106 Venue FitIYN2024-06-10 View

Page 1 of 4

↑