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

GE Healthcare

FDA 510(k) & PMA Approved Devices — 57 products

Total Devices57
Categories15
Latest Approval2026-01-08
TypeNumberDevice NameCodeDate
510(k) K253639 View LLZ 2026-01-08 View
510(k) K242925 MR Contour DL QKB 2025-04-01 View
510(k) K232346 Digital Expert Access with Remote Scanning LNH 2023-10-27 View
510(k) K223212 Precision DL KPS 2023-04-27 View
510(k) K221680 Xeleris V Processing and Review System LLZ 2023-03-01 View
510(k) K221932 Omni Legend KPS 2022-09-02 View
510(k) K213689 Voluson P6, Voluson P8 IYN 2022-02-17 View
510(k) K213642 Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert IYN 2022-01-13 View
510(k) K211488 LOGIQ E10 IYN 2021-09-10 View
510(k) K212004 MyoSPECT, MyoSpect ES KPS 2021-08-27 View
510(k) K211524 LOGIQ E10s, LOGIQ Fortis IYN 2021-08-27 View
510(k) K211725 Senographe Pristina MUE 2021-08-06 View
510(k) K211215 SenoBright HD MUE 2021-06-22 View
510(k) K211312 Universal Viewer LLZ 2021-05-21 View
510(k) K210173 StarGuide KPS 2021-03-29 View
510(k) K201628 Panda iRes Warmer, Giraffe Warmer FMT 2021-02-12 View
510(k) K201768 Voluson E10 IYN 2020-10-22 View
510(k) K201103 Xeleris V Processing and Review Systems LLZ 2020-09-25 View
510(k) K193334 Pristina Serena Bright MUE 2020-05-15 View
510(k) K200494 CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES MHX 2020-03-29 View
510(k) K190008 Carescape One MHX 2019-12-20 View
510(k) K192159 Voluson E6, Voluson E8, Voluson E10 IYN 2019-08-29 View
510(k) K190809 Sample Imaging for Senographe Pristina MUE 2019-07-29 View
510(k) K182951 Pristina Serena 3D MUE 2019-01-18 View
510(k) K182419 Centricity Universal Viewer LLZ 2018-12-14 View
510(k) K183116 Unity Network ID MWI 2018-12-06 View
510(k) K181985 Voluson E6, Voluson E8, Voluson E10 IYN 2018-11-15 View
510(k) K181403 Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR OWB 2018-11-02 View
510(k) K182590 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA MOS 2018-10-19 View
510(k) K181783 LOGIQ P9; LOGIQ P7 IYN 2018-09-20 View
510(k) K173576 Pristina Serena MUE 2018-05-14 View
510(k) K180641 Invenia ABUS Viewer LLZ 2018-05-04 View
510(k) K173816 NM/CT 850, NM/CT 860 KPS 2018-04-17 View
510(k) K180535 Voluson P6 and Voluson P8 IYN 2018-03-29 View
510(k) K180374 Voluson S8/ Voluson S10/ Voluson S10 Expert IYN 2018-03-13 View
PMA P130020 Digital breast tomosynthesis OTE 2017-12-28 View
510(k) K173555 LOGIQ E10 IYN 2017-12-20 View
510(k) K172404 SenoBright HD MUE 2017-10-30 View
510(k) K172342 Voluson E6, Voluson E8, Voluson E10 IYN 2017-09-29 View
PMA P110006 Automated breast ultrasound PAA 2017-09-07 View
510(k) K163302 Senographe Pristina MUE 2017-09-01 View
510(k) K170199 Unity Network ID MWI 2017-05-12 View
510(k) K170445 LOGIQ S8 IYN 2017-04-11 View
510(k) K163596 LOGIQ P9 and LOGIQ P7 IYN 2017-02-10 View
510(k) K160933 Discovery NM 750b Bopsy IYX 2016-11-18 View
510(k) K162268 Senographe Pristina MUE 2016-11-03 View
510(k) K162269 Voluson E6, Voluson E8, Voluson E10 IYN 2016-10-03 View
510(k) K162012 CARESCAPE Central Station V2 DXJ 2016-09-15 View
510(k) K161567 SIGNA Voyager LNH 2016-09-01 View
510(k) K160937 Senolris LLZ 2016-08-01 View
510(k) K161047 LOGIQ P9 and LOGIQ P7 IYN 2016-05-05 View
510(k) K160162 Voluson P6, Voluson P8 IYN 2016-04-26 View
510(k) K160621 SIGNAPioneer LNH 2016-03-29 View
510(k) K153355 Xeleris 4.0 Processing and Review Workstation LLZ 2016-03-16 View
510(k) K160182 LOGIQ S7 Expert IYN 2016-02-26 View
510(k) K160184 Voluson S6, Voluson S8, Voluson S10 IYN 2016-02-25 View
510(k) K153402 Discovery NM/CT 670 CZT KPS 2016-01-21 View
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