GE Medical Systems Ultrasound and Primary Care Diagnostics

FDA 510(k) & PMA Approved Devices — 61 products

Total Devices61

Categories4

Latest Approval2026-03-24

Type	Number	Device Name	Code	Date
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 Power	IYN	2026-03-24	View
510(k)	K253370	LOGIQ Totus	IYN	2026-01-08	View
510(k)	K253366	LOGIQ Fortis	IYN	2026-01-07	View
510(k)	K252328	Voluson Expert 18; Voluson Expert 20; Voluson Expert 22	IYN	2025-11-24	View
510(k)	K251985	LOGIQ E10	IYN	2025-10-29	View
510(k)	K251963	LOGIQ E10s	IYN	2025-10-29	View
510(k)	K251322	Venue; Venue Go; Venue Fit; Venue Sprint	IYN	2025-07-25	View
510(k)	K251342	EchoPAC Software Only / EchoPAC Plug-in	QIH	2025-07-16	View
510(k)	K251169	Vivid Pioneer	IYN	2025-07-10	View
510(k)	K250543	Voluson Performance 16; Voluson Performance 18	IYN	2025-05-29	View
510(k)	K250087	Vscan Air	IYN	2025-05-01	View
510(k)	K243620	Vivid iq	IYN	2025-02-11	View
510(k)	K243628	Vivid T9/Vivid T8	IYN	2025-02-11	View
510(k)	K242168	Voluson Expert 18; Voluson Expert 20; Voluson Expert 22	IYN	2024-12-20	View
510(k)	K242005	Versana Premier; Versana Premier Lotus; LOGIQ F	IYN	2024-10-02	View
510(k)	K240053	Venue Go	IYN	2024-06-10	View
510(k)	K240206	Venue Sprint	IYN	2024-06-10	View
510(k)	K234106	Venue Fit	IYN	2024-06-10	View
510(k)	K240111	Venue	IYN	2024-06-10	View
510(k)	K233692	Voluson Signature 20, Voluson Signature 18	IYN	2024-03-07	View
510(k)	K232381	LOGIQ Totus	IYN	2023-12-07	View
510(k)	K231966	LOGIQ E10	IYN	2023-11-07	View
510(k)	K231965	Voluson Expert 22, Voluson Expert 20, Voluson Expert 18	IYN	2023-10-30	View
510(k)	K231301	Vscan Air	IYN	2023-08-15	View
510(k)	K223407	Versana Essential	IYN	2023-02-15	View
510(k)	K220940	EchoPAC Software Only, EchoPAC Plug-in	QIH	2022-07-22	View
510(k)	K221147	Vivid T8, Vivid T9	IYN	2022-07-18	View
510(k)	K220619	Vivid S60N, Vivid S70N	IYN	2022-07-15	View
510(k)	K220800	Venue Go	IYN	2022-06-21	View
510(k)	K220358	Voluson Expert 22, Voluson Expert 20, Voluson Expert 18	IYN	2022-06-06	View
510(k)	K220446	Versana Balance	IYN	2022-05-11	View
510(k)	K214039	LOGIQ P10, LOGIQ P9, LOGIQ P8	IYN	2022-03-22	View
510(k)	K210438	Versana Premier	IYN	2021-09-10	View
510(k)	K211216	Vivid S60N / Vivid S70N	IYN	2021-06-09	View
510(k)	K202658	Vivid E80/ Vivid E90/ Vivid E95	IYN	2021-03-05	View
510(k)	K203114	LOGIQ P10, LOGIQ P9, LOGIQ P8	IYN	2021-01-08	View
510(k)	K203137	Venue Fit	IYN	2020-12-29	View
510(k)	K202035	Vscan Air	ITX	2020-11-20	View
510(k)	K202233	Venue Go	IYN	2020-11-18	View
510(k)	K202132	Venue	IYN	2020-11-13	View
510(k)	K201828	Voluson SWIFT, Voluson SWIFT+	IYN	2020-10-11	View
510(k)	K200852	EchoPAC Software Only, EchoPAC Plug-In	LLZ	2020-09-18	View
510(k)	K200851	Vivid T8, Vivid T9	IYN	2020-09-09	View
510(k)	K200497	Vivid S60N, Vivid S70N	IYN	2020-07-16	View
510(k)	K200998	Versana Active	IYN	2020-06-11	View
510(k)	K200119	LOGIQ E10s	IYN	2020-04-01	View
510(k)	K191798	Versana Active	IYN	2019-08-09	View
510(k)	K191792	Versana Balance	IYN	2019-08-09	View
510(k)	K183362	Venue GO	IYN	2019-01-28	View
510(k)	K182750	4D View	LLZ	2018-12-21	View
510(k)	K181727	Vivid iq	IYN	2018-12-06	View
510(k)	K182277	Versana Premier	IYN	2018-11-21	View
510(k)	K181685	Vivid E80, Vivid E90, Vivid E95	IYN	2018-10-25	View
510(k)	K182450	Vivid S60N, Vivid S70N	IYN	2018-10-19	View
510(k)	K180995	Vscan Extend	IYN	2018-06-25	View
510(k)	K180599	Venue	IYN	2018-05-02	View
510(k)	K170847	EchoPAC Software Only, EchoPAC Plug-in	LLZ	2017-06-14	View
510(k)	K170823	Vivid E80, Vivid E90, Vivid E95	IYN	2017-06-12	View
510(k)	K162743	ViewPoint 6	LLZ	2016-11-22	View
510(k)	K163077	LOGIQ E9, LOGIQ E9 XDClear 2.0	IYN	2016-11-17	View
510(k)	K160277	LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6	IYN	2016-03-25	View