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 Healthcare

FDA 510(k) & PMA Approved Devices — 152 products

Total Devices152
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K253639 ViewLLZ2026-01-08 View
510(k) K242925 MR Contour DLQKB2025-04-01 View
510(k) K232346 Digital Expert Access with Remote ScanningLNH2023-10-27 View
510(k) K223212 Precision DLKPS2023-04-27 View
510(k) K221680 Xeleris V Processing and Review SystemLLZ2023-03-01 View
510(k) K221932 Omni LegendKPS2022-09-02 View
510(k) K213689 Voluson P6, Voluson P8IYN2022-02-17 View
510(k) K213642 Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertIYN2022-01-13 View
510(k) K211488 LOGIQ E10IYN2021-09-10 View
510(k) K211524 LOGIQ E10s, LOGIQ FortisIYN2021-08-27 View
510(k) K212004 MyoSPECT, MyoSpect ESKPS2021-08-27 View
510(k) K211725 Senographe PristinaMUE2021-08-06 View
510(k) K211215 SenoBright HDMUE2021-06-22 View
510(k) K211312 Universal ViewerLLZ2021-05-21 View
510(k) K210173 StarGuideKPS2021-03-29 View
510(k) K201628 Panda iRes Warmer, Giraffe WarmerFMT2021-02-12 View
510(k) K201768 Voluson E10IYN2020-10-22 View
510(k) K201103 Xeleris V Processing and Review SystemsLLZ2020-09-25 View
510(k) K193334 Pristina Serena BrightMUE2020-05-15 View
510(k) K200494 CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESMHX2020-03-29 View
↑