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GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories4
Latest FDA decision2026-04-20
TypeNumberDevice NameCodeDateActions
510(k) K252718 Lunar AstraKGI2026-04-20 View
510(k) K254161 Automated Aortic Stenosis Software (AutoAS)POK2026-03-27 View
510(k) K221148 Vivid iqIYN2022-07-18 View
510(k) K203677 ViewPoint 6LLZ2021-01-15 View
510(k) K200158 LOGIQ E10IYN2020-04-17 View
510(k) K191112 GEHC DXA Bone Densitometers with enCORE version 18KGI2019-09-19 View
510(k) K181934 Vivid T8, Vivid T9IYN2018-11-06 View
510(k) K180782 AriaKGI2018-04-20 View
510(k) K170714 VenueIYN2017-06-21 View
510(k) K170878 Vivid S60N, Vivid S70NIYN2017-06-14 View
510(k) K161682 GE Lunar DXA Bone Densitometers with enCORE version 17KGI2016-12-02 View
510(k) K161588 Vscan ExtendIYN2016-08-31 View
510(k) K161224 LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3IYN2016-08-05 View
510(k) K153037 LOGIQ V1/ LOGIQ V2IYN2016-01-04 View
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