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) K240111 VenueIYN2024-06-10 View
510(k) K233692 Voluson Signature 20, Voluson Signature 18IYN2024-03-07 View
510(k) K232381 LOGIQ TotusIYN2023-12-07 View
510(k) K231966 LOGIQ E10IYN2023-11-07 View
510(k) K231965 Voluson Expert 22, Voluson Expert 20, Voluson Expert 18IYN2023-10-30 View
510(k) K231301 Vscan AirIYN2023-08-15 View
510(k) K223407 Versana EssentialIYN2023-02-15 View
510(k) K220940 EchoPAC Software Only, EchoPAC Plug-inQIH2022-07-22 View
510(k) K221147 Vivid T8, Vivid T9IYN2022-07-18 View
510(k) K220619 Vivid S60N, Vivid S70NIYN2022-07-15 View
510(k) K220800 Venue GoIYN2022-06-21 View
510(k) K220358 Voluson Expert 22, Voluson Expert 20, Voluson Expert 18IYN2022-06-06 View
510(k) K220446 Versana BalanceIYN2022-05-11 View
510(k) K214039 LOGIQ P10, LOGIQ P9, LOGIQ P8IYN2022-03-22 View
510(k) K210438 Versana PremierIYN2021-09-10 View
510(k) K211216 Vivid S60N / Vivid S70NIYN2021-06-09 View
510(k) K202658 Vivid E80/ Vivid E90/ Vivid E95IYN2021-03-05 View
510(k) K203114 LOGIQ P10, LOGIQ P9, LOGIQ P8IYN2021-01-08 View
510(k) K203137 Venue FitIYN2020-12-29 View
510(k) K202035 Vscan AirITX2020-11-20 View

Page 2 of 4